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Available Positions

Blaster


Company: IMIA, LLC
Job Ref: # 6569102
Date Posted: 10/2/2025 12:00:00 AM
City, State: Jacksonville, FL

Description

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JOB TITLE: Blaster

REPORTS TO: Blast Foreman


Summary of position:
  • Responsible for blasting any surface to the correct degree of surface preparation.
  • Perform repairs to hoses, lines and isolated equipment.
  • Must be capable of working in dark spaces with other blasters in close proximity.


Essential Job Requirements:
  • Perform very physical duties under leadership of Blast Foreman.
  • Blast surface to standard specified without leaving faulty areas.
  • Assist in setting up for the job; assist in training of other workers as necessary; complete work with little or no supervision
  • Must be knowledgeable of OSHA requirements relative to the ship building industry
  • Must comply with company, federal, state, and local safety and environmental rules and regulations
  • Accurately operate, clean, and maintain all equipment
  • Must be able to follow directions
  • Must be able to communicate effectively in writing or orally
  • Lead small work groups on job as assigned
  • Efficiently and correctly interpret and work from owner supplied drawings, job specifications, instruction manuals, manufacturer’s handbooks, change orders, and contract specifications.
  • May be required to use water blaster at different times
  • May be required to perform additional duties as deemed necessary by the Blast Foreman or Superintendent

Required Education:

  • Must be capable of taking verbal direction.
  • Ability to read and write with understanding.
Required Experience:
  • Formal or informal on the job training and 2 years experience in the Marine Industry.
Required Skills:
  • Must be very productive while blasting interior or exterior surfaces. Maintain safety at all times. Must be able to read and interpret documents as necessary, such as operating and maintenance manuals, safety rules and regulations, procedure manuals, etc.
  • Must be able to work cooperatively and productively with other employees and shipyard personnel.
  • Must take direction and carry out the specified work scope.
Physical Requirements:
  • Regularly required to walk; frequently required to stand, stoop, kneel, crouch, climb, balance, or crawl at various heights and in confined spaces
  • Occasionally required to sit; required to reach with hands and arms, use hands to feel, grip, or handle
  • Regularly required to safely lift and/or move up to 50 pounds
  • Required use of vision to see up close, distance, and peripherally, as well as depth perception and ability to adjust focus in low light conditions
  • May be required to wear a respirator to safely perform assigned tasks.
Mental Requirements:
  • Must be able to carry out simple to complex oral, written, or diagramed instructions safely and efficiently. Must be able to solve simple problems inside tank while blasting.
  • Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform essential job functions.
Equipment Used:
  • Blast Pot/Hopper, after cooler, dehumidifiers, dust collectors, vacuums, forklifts, electrical disconnects and transformers, compressors.
Supervisory Responsibilities:
  • Help with new blasters.
Working Conditions:
  • Typical work environment is dusty, noisy, and confined.
  • Exposure to extreme temperatures, chemicals, fumes, ambient weather conditions, and hazardous machinery is characteristic as well.
  • Often works on scaffolds and ladders.
  • To avoid injury, safety clothing required along with safety devices to protect eyes, head, or hearing.
  • Travel, prolonged periods of overtime and varying shifts are required in the performance of this job.




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SHT Mechanic


Company: IMIA, LLC
Job Ref: # 9351119
Date Posted: 10/2/2025 12:00:00 AM
City, State: Norfolk, VA

Description

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SHT Mechanic

About the Organization

IMIA, LLC is the only national marine surface preparation painting contractor servicing every U.S. Port with a mobile full time workforce that ensures that a quality product is delivered on time every time. IMIA, LLC has the equipment, seasoned deckplate supervision and mechanics, as well as rigorous corporate safety and quality programs and financial strength to support our customer's preservation needs in a truly superior and comprehensive fashion.

IMIA, LLC offers a comprehensive benefit package to eligible employees. Eligible employees may enroll in:

  • Health
  • Dental
  • Vision
  • Life
  • LTD
  • Accident
  • Critical Illness
  • 401k

Employees and their household members are also eligible to participate in the company's Employee Assistance Program.

Per Diem OR Dislocation Allowance may be provided to eligible employees to reimburse some or all of the cost an employee might be reasonably expected to incur for lodging, meals, and incidental expenses while traveling out of town for work.

EOE Statement

IMIA, LLC is an equal opportunity employer and provides equal employment opportunities (EEO) to all employees regardless of race, color, religion, gender, gender identity or expression, national origin, sexual orientation, age, sex, disability status, marital status, status as a covered veteran, genetics, or any other protected groups under state, federal or local Equal Opportunity Laws. This policy applies to all terms and conditions of employment including but not limited to hiring, placement, promotion, termination, layoff, recall, transfer, leave of absence, compensation, and training.

Description

JOB TITLE: SHT Mechanic

REPORTS TO: Superintendent

SUMMARY

Removal and installation of hull treatment and non-metallic coatings on United States Navy nuclear-powered submarines. Position requires a willingness to learn, dependability, and the ability to think critically.

ESSENTIAL DUTIES & RESPONSIBILITIES

Ensure work is done safely and meets quality standards.

Ability to perform carpentry-type duties to include use of manual tools, power tools, and building of containments.

Read and interpret documents as necessary, such as operating and maintenance manuals, safety rules and regulations, procedure manuals, etc.

May prepare molds and templates for fabrication of hull treatment.

Maintain a clean work environment where coatings work is being performed.

Demonstrate comprehension of complex shapes and the ability to understand symmetrical gaps both parallel and perpendicular to the ships surface shape.

Mixing of different types of solvent and adhesive materials.

Use of troweling tools and adhesives, and work with equipment specific to hull treatment installations

Understanding fairness and flushness with regards to surface preparation.

Follow all company rules and policies.

Provide a great level of attention to detail and focus on the given task.

May be required to perform additional duties as deemed necessary by the Superintendent.

Must be willing to comply with clean shaven standards needed to wear half/full face respirator.

Must be able to pass a thorough background investigation to obtain access into a shipyard environment.

PREFERRED EXPERIENCE

Commercial Carpentry

Ceramic or Composite Tile Installation

Shipyard, Manufacturing, or Industrial Experience

KNOWLEDGE, SKILLS, AND ABILITIES

Must be able to work cooperatively and productively with other employees and shipyard personnel.

Must be able identify and measure material.

Must be able to calculate basic figures.

Must be able to carry out instructions furnished in oral, written, or diagram form.

Must be able to problem solve, organize, and prioritize work.

Must be able to perform required duties efficiently and independently.

EDUCATION

None

WORKING CONDITIONS

Regularly exposed to extreme temperatures, high noise levels, toxic or caustic chemicals, fumes, airborne particles, outdoor weather conditions, dusty conditions, wet and/or humid conditions, hazardous machinery, confined spaces, precarious places, proximity to other employees. To avoid injury, safety clothing is required along with safety devices to protect eyes, mouth, or hearing.

Regularly required to walk; frequently required to stand, stoop, kneel, crouch, climb, balance, or crawl, occasionally required to sit, required to reach with hands and arms, use hands to feel, grip, or handle, regularly required to lift and/or move up to 50 pounds, required use of vision to see up close, distance, and peripherally, as well as depth perception and ability to adjust focus.

Shift work is involved most of the time. Travel may be required. Mandatory overtime will be required.

EQUIPMENT USED

Various

SUPERVISORY RESPONSIBILITIES

None

REASONABLE ACCOMMODATIONS

May be made to enable qualified individuals with disabilities to perform essential job functions.

Location Portsmouth, VA

Salary Range Non-Exempt



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Technical Trainer


Job Ref: # 2942118
Date Posted: 10/1/2025 7:24:46 PM
City, State: Orlando, FL

Description

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In this role, you will have the opportunity to make a significant impact on the growth and development of the organization’s technical knowledge. The Field Service Technical Trainer will work with field engineers worldwide, equipping them with the skills to maintain and repair power generation equipment.

Duties and Responsibilities:

  • Design, develop, and deliver employee technical training on company and legacy large-frame turbine generator equipment
  • Evaluate training effectiveness and recommend improvements
  • Identify training needs through observation and skill assessments
  • Collaborate with managers and other trainers to align training with company goals
  • Stay up to date with industry advancements
  • Approximately 15% travel required to deliver or gather information for training
  • Primary work location: Orlando or another company hub (Pittsburgh PSC, Deer Park TX, Charlotte)


Requirements:
  • 5+ years of field experience with power plant turbines and generators
  • Bachelor's degree in industrial technology, engineering, or equivalent experience
  • Experience as a Gas and/or Steam Turbine Power Plant Service Engineer
  • Strong public speaking and classroom facilitation skills
  • Ability to create engaging training programs
  • Excellent organizational and project management skills
  • Formal training/education certifications are a plus




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MEP Superintendent


Job Ref: # 7304460
Date Posted: 10/1/2025 1:52:44 PM
City, State: Chantilly, VA

Description

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The Data Center MEP Superintendent is a mission-critical, on-site role responsible for the direct execution, supervision, and coordination of all Mechanical, Electrical, and Plumbing (MEP) trades for complex, hyper-scale data center construction projects across Northern Virginia. This role is accountable for managing construction quality and readiness through the rigorous Level 3 Functional Performance Testing (FPT).

Key Responsibilities

Training and Development
  • Successfully complete a structured 3 to 6-month hands-on training program at an existing company Critical site, working directly under experienced MEP Superintendents.
  • Master site-specific procedures, safety protocols, quality assurance standards, and the meticulous documentation required for hyper-scale environments.

On-Site Execution & Quality (Levels 1-3)

  • Directly manage and coordinate the daily work of all MEP trades and subcontractors, ensuring strict adherence to the project schedule and specifications.
  • Oversee and execute the General Contractor's scope of Commissioning (Levels 1, 2, and 3), focused on Construction Checklists, Pre-Functional Tests (PFTs), and Functional Performance Testing (FPTs).
  • Ensure all Pre-Functional Checklists (PFCs) and FPT documentation are meticulously completed, signed off, and prepared for seamless handover to the Owner's Level 4/5 Cx team.
  • Direct the safe and efficient rigging and placement of heavy MEP equipment (generators, chillers, UPS units, switchgear) with strict tolerance standards.
  • Enforce zero-tolerance policies for contamination and debris in raised floor areas, electrical rooms, and air handling systems.

Coordination & Documentation

  • Actively participate in BIM coordination meetings to preemptively resolve field installation conflicts (clash detection).
  • Maintain detailed daily reports documenting manpower, progress, material deliveries, and critical MEP tie-in/shutdown procedures.
  • Manage the RFI (Request for Information) and submittal review processes for all MEP scopes.
Required Qualifications
  • Experience: 5+ years of progressive experience as an MEP Superintendent, Foreman, or equivalent role, with a minimum of 3 years dedicated to mission-critical data center construction.
  • Technical Expertise: Deep working knowledge of complex data center MEP systems (e.g., redundancy, low/medium voltage, cooling infrastructure) and the testing protocols for Levels 1, 2, and 3 commissioning.
  • Education/Certifications: High School Diploma or equivalent; OSHA 30 required.




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Senior Product Compliance Analyst


Company: Orion Talent
Job Ref: # 5952920
Date Posted: 10/1/2025 12:00:00 AM
City, State: Plymouth, MN

Description

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Schedule: M-F, daytime hours
Compensation: 100k
Benefits: Competitive Benefits package!
Travel: minimal

Position
Description:

  • The Senior Product Compliance Analyst is focused on product
    compliance to regulatory requirements for medical devices in the US, Canada and
    in various other countries. This role ensures our products meet all applicable
    regulatory standards for safety, efficacy, and quality. The position works
    across departments to prepare and submit applications for product approvals,
    licenses, and permits, and monitor post-market compliance. They also advise on
    regulatory requirements during product development, manufacturing, distribution
    and service.

Core
Responsibilities:

  • The Senior Product Compliance Analyst will develop US,
    Canada and emerging market assessments and submissions for complex projects and
    review issues related to regulatory documents, investigations, product
    development planning and regulatory agency interaction
  • The Senior Product Compliance Analyst will assist in
    training staff for regulatory requirements as part of the role
  • Perform facility inspections for compliance to 21CFR820 and
    ISO13485 Evoqua policy and procedures assuring compliant operation
  • Conduct appropriate research using standards, guidance
    documents, previous assessments and other resources to develop strong
    regulatory assessments for new and modified products
  • Assume responsibility for project submissions for 510(k)
    premarket notifications, Technical File Documentation, and license
    submission/amendments
  • Communicate with management to ensure timely notification of
    regulatory changes as appropriate
  • Work with Quality, Operations, Engineering, and other
    internal groups to investigate and recommend solutions to address potential
    regulatory issues and impacts
  • Interact and negotiate with regulatory authorities during
    the development (i.e Q-Sub, change notifications, etc.) and submission review
  • Support regulatory agency and/or notified body audits by as
    needed
  • Participate in development and approval of risk activities
    as well as other deliverables as related to medical device projects
  • Review and approve all Labeling (product, advertising and
    promotional) and ensure claims are substantiated
  • Monitor impact of changing evolving global regulations on
    submissions, practices and procedures and communicate to internal stakeholders
  • Support customer inquiry related to compliance issues
  • Comply with Code of Ethics, all Company policies, rules, and
    procedures

Requirements:

  • Bachelor's degree in a Science or Engineering field, or
    equivalent work experience
  • 5+ years of Medical Device Regulatory Affairs experience,
    domestic and international
  • 3 years of experience with Class II or III medical devices
  • Proven history of successful domestic and/or international
    submissions
  • Strong analytical and critical thinking skills
  • Strong verbal and writing communication skills
  • Ability to manage and prioritize multiple projects to meet
    deadlines that align with our objectives
  • Proven track record of working as a team player to overcome
    obstacles and complete tasks through collaboration
  • Proficiency in MS Office software programs




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QC Manager


Company: BEC Machine Products
Job Ref: # 9832873
Date Posted: 10/1/2025 12:00:00 AM
City, State: Harleysville, PA

Description

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Position Summary: The QC Manager oversees all aspects of quality control and calibration across machining operations. This role ensures compliance with internal standards and customer requirements, manages inspection workflows, supports audits, and drives corrective action. The QC Manager works closely with production and process control to resolve issues and improve processes.
Key Responsibilities:
  • Lead QC staff and manage daily inspection activities
  • Maintain quality procedures, documentation, and inspection protocols
  • Oversee incoming, in-process, and final inspections of machined components
  • Ensure compliance with ISO 9001, MIL-I, and SAE standards
  • Investigate non-conformances and implement corrective/preventive actions
  • Manage calibration schedules and records for all measurement equipment
  • Ensure traceability and documentation of calibration activities
  • Analyze quality data to identify trends and improvement opportunities
  • Collaborate across departments to resolve quality issues
Qualifications:
  • 3+ years of QC experience in machining or manufacturing
  • Strong understanding of machining tolerances, inspection methods, and GD&T (Geometric Dimensioning and Tolerancing) symbols.
  • Proficient with measurement tools (Dial calipers, micrometers, profilometers, thread measuring wires, height stands etc.) and calibration practices.
  • Experience with the use of Optical Comparators
  • Experience with ISO 9001, MIL-I, and SAE standards
  • Effective communicator with solid documentation skills
  • Able to lead, train, and support a team
  • Familiarity with quality software and reporting tools is a plus
Benefits:
  • Hourly rate ($24–$32/hour) – Based on Experience
  • 401K with match
  • Health, dental, and vision insurance
  • Paid time off and holidays
  • Team-oriented work environment




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Quality Engineer


Company: Precinmac
Job Ref: # 7030781
Date Posted: 10/1/2025 12:00:00 AM
City, State: Chicopee, MA

Description

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Quality Engineer


Salary Range:$80,000.00 To $100,000.00 Annually
 
We’re growing! Apply now and be part of a world-renowned, award-winning team!

Precinmac is a leading supplier of mission-critical, precision machined components used in the Aerospace, Defense and Space (AD&S) markets. We specialize in manufacturing uniquely designed high tolerance precision machined components and assemblies, with a focus on continuous improvement, on-time delivery, and the highest possible quality and consistency.

Location: Hoppe Technologies Inc. (Chicopee, MA)
Title of position: Quality Engineer
Position type: Full Time
Description of Responsibilities:
Hoppe Technologies, located in Chicopee, Massachusetts, is currently recruiting to fill a Quality Engineer position with a focus on Aerospace, Defense and Space components and their associated requirements. Responsibilities of the Quality Engineer include, but are not limited to;
  • Ensure compliance with AS9100, NADCAP, and all industry regulations and requirements.
  • Hands on inspection relying on CMM programming and fixture design knowledge and experience.
  • Provide direct technical support to the shop floor to troubleshoot and resolve various manufacturing concerns.
  • Lead cross-functional teams through 8D Root Cause and Corrective Actions to resolve internal and external non-conformances.
  • Perform internal AS9100 audits. Support and participate in annual surveillance (or recertification) audits with external auditor.
  • Member of the engineering team and key contributor to New Product Introduction (NPI) with a focus on manufacturability, process capability, and determining future improvements.
  • Perform other duties as assigned by supervisor.
Required Experience:
  • Absolutely MUST have a minimum of three to five years of recent experience in a Quality Engineering role in a Machine Shop / Machining Company that supports the Aerospace, Defense, or Space markets.
Required Skills:
  • Bachelor of Science degree in Manufacturing, Industrial, Mechanical Engineering or similar.
  • Strong understanding of the quality requirements and standards necessary to be an Aerospace, Defense, and Space supplier.
  • Able to create, troubleshoot and improve CMM programs using Zeiss Calypso.
  • Able to design and assist in the fabrication of CMM fixtures.
  • Knowledge of gages, calipers, micrometers, indicators, hand tools, set rings, gage blocks, custom gages and all similar manual inspection tools.
  • Able to read and interpret complex part drawings and models with strong knowledge of GD&T.
  • Project management skill set.
  • Previous formal training and certification in 8D problem solving and internal auditing (AS9100).




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Parts Account Representative (Outside Sales)


Job Ref: # 3650282
Date Posted: 10/1/2025 12:00:00 AM
City, State: Philadelphia, PA

Description

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We are excited to add a Parts Account Representative/Outside Parts Sales Representative to our team in Southeast PA and South-Central NJ.

At Wolfington Body Company, one of the country’s leading International school bus dealer's, our success depends on serving our customers with the best team members in the industry. If your career goals include making a valuable contribution as a Parts Account Representative in an exciting and growing company while working with top professionals in the industry, then consider joining our team. We are seeking enthusiastic, hard-working, customer-oriented individuals who can work in a team environment. The parts specialist builds
sales by developing customer relationships, problem solving, and serving as a conduit between our clients and our Parts and Service experts.

 
Primary Responsibilities
  • Manages a territory consisting of Southeastern Pennsylvania and South-Central New Jersey
  • Must be capable of speaking to all products including but not limited to parts, service, and technology products
  • Maintain constant communication with WBC Parts Experts for product information and conflict resolution
  • Prospect for new accounts/referrals which include compiling and updating a list of prospective clients to provide leads for business opportunities
  • Maintain existing account relationships and be alert for ancillary opportunities to increase penetration
  • Develop, implement, and maintain comprehensive account specific growth strategies
  • Service existing accounts and communicate with clients on a regular basis. Discuss use and features of various parts, services, and ongoing promotions
  • Communicate concerns to the appropriate experts within WBC
  • Update account profiles for monthly meetings for information regarding sales potential
  • Follow up on orders to ensure that customers are served promptly
  • Coordinate parts and service sales with the appropriate personnel; Advise counterperson on special requirements/requests
  • Obtains orders by explaining product benefits; reviewing business plans; analyzing sales volume; introducing new products; relays orders to call-center
  • Updates CRM software with potential leads, business opportunities, and follow-ups 
  • Focuses on professional and personal improvement through participating in educational opportunities; reading industry publications; maintaining personal networks; participating in professional organizations
 
  • This is a field-based position; candidates must be disciplined and well-organized
  • Ability to work independently
  • Exceptional documentation skills
  • Sale experience is preferred; our approach is unique and we will train the right individual
  • Demonstrates sales ability with a successful track record
  • Experience in route planning and follow-up
  • Excellent social skills & strong attention to detail
  • Strong written/verbal communication skills required
  • Highly self-motivated and goal-oriented
  • Enthusiastic relationship builder
  • Entrepreneurial spirit; driven to succeed and to grow
  • Mechanical Aptitude
  • High school diploma required/ College Education preferred
  • Valid Driver’s license required
 
Preferred Qualifications
  • Knowledge of dealer and fleet maintenance procedures and systems
  • Knowledge of bus, medium duty truck, and/or automotive parts
  • Working knowledge of International and supplier/vendor warranty policies
 
Job Type: Full-time


Benefits:
  • Company Car
  • 401(k)
  • 401(k) matching
  • Dental insurance
  • Health insurance
  • Vision insurance
  • Paid time off
Schedule:
  • 8 hour shift
Work Location: On the road




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Senior Product Compliance Analyst


Company: Orion Talent
Job Ref: # 1382250
Date Posted: 10/1/2025 12:00:00 AM
City, State: Remote, United States

Description

Go to end  ⇓
Title: Senior Product Compliance Analyst
Location: Plymouth, MN (Remote)
Schedule: M-F, daytime hours
Compensation: 100k
Benefits: Competitive Benefits package!
Travel: minimal

Position
Description:

  • The Senior Product Compliance Analyst is focused on product
    compliance to regulatory requirements for medical devices in the US, Canada and
    in various other countries. This role ensures our products meet all applicable
    regulatory standards for safety, efficacy, and quality. The position works
    across departments to prepare and submit applications for product approvals,
    licenses, and permits, and monitor post-market compliance. They also advise on
    regulatory requirements during product development, manufacturing, distribution
    and service.

Core
Responsibilities:

  • The Senior Product Compliance Analyst will develop US,
    Canada and emerging market assessments and submissions for complex projects and
    review issues related to regulatory documents, investigations, product
    development planning and regulatory agency interaction
  • The Senior Product Compliance Analyst will assist in
    training staff for regulatory requirements as part of the role
  • Perform facility inspections for compliance to 21CFR820 and
    ISO13485 Evoqua policy and procedures assuring compliant operation
  • Conduct appropriate research using standards, guidance
    documents, previous assessments and other resources to develop strong
    regulatory assessments for new and modified products
  • Assume responsibility for project submissions for 510(k)
    premarket notifications, Technical File Documentation, and license
    submission/amendments
  • Communicate with management to ensure timely notification of
    regulatory changes as appropriate
  • Work with Quality, Operations, Engineering, and other
    internal groups to investigate and recommend solutions to address potential
    regulatory issues and impacts
  • Interact and negotiate with regulatory authorities during
    the development (i.e Q-Sub, change notifications, etc.) and submission review
  • Support regulatory agency and/or notified body audits by as
    needed
  • Participate in development and approval of risk activities
    as well as other deliverables as related to medical device projects
  • Review and approve all Labeling (product, advertising and
    promotional) and ensure claims are substantiated
  • Monitor impact of changing evolving global regulations on
    submissions, practices and procedures and communicate to internal stakeholders
  • Support customer inquiry related to compliance issues
  • Comply with Code of Ethics, all Company policies, rules, and
    procedures

Requirements:

  • Bachelor's degree in a Science or Engineering field, or
    equivalent work experience
  • 5+ years of Medical Device Regulatory Affairs experience,
    domestic and international
  • 3 years of experience with Class II or III medical devices
  • Proven history of successful domestic and/or international
    submissions
  • Strong analytical and critical thinking skills
  • Strong verbal and writing communication skills
  • Ability to manage and prioritize multiple projects to meet
    deadlines that align with objectives
  • Proven track record of working as a team player to overcome
    obstacles and complete tasks through collaboration
  • Proficiency in MS Office software programs
  •  



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Senior Product Compliance Analyst


Company: Orion Talent
Job Ref: # 1597784
Date Posted: 10/1/2025 12:00:00 AM
City, State: Charlotte, NC

Description

Go to end  ⇓
Location: Plymouth, MN
Schedule: M-F, daytime hours
Compensation: 100k
Benefits: Competitive Benefits package!
Travel: minimal

Position
Description:

  • The Senior Product Compliance Analyst is focused on product
    compliance to regulatory requirements for medical devices in the US, Canada and
    in various other countries. This role ensures our products meet all applicable
    regulatory standards for safety, efficacy, and quality. The position works
    across departments to prepare and submit applications for product approvals,
    licenses, and permits, and monitor post-market compliance. They also advise on
    regulatory requirements during product development, manufacturing, distribution
    and service.

Core
Responsibilities:

  • The Senior Product Compliance Analyst will develop US,
    Canada and emerging market assessments and submissions for complex projects and
    review issues related to regulatory documents, investigations, product
    development planning and regulatory agency interaction
  • The Senior Product Compliance Analyst will assist in
    training staff for regulatory requirements as part of the role
  • Perform facility inspections for compliance to 21CFR820 and
    ISO13485 Evoqua policy and procedures assuring compliant operation
  • Conduct appropriate research using standards, guidance
    documents, previous assessments and other resources to develop strong
    regulatory assessments for new and modified products
  • Assume responsibility for project submissions for 510(k)
    premarket notifications, Technical File Documentation, and license
    submission/amendments
  • Communicate with management to ensure timely notification of
    regulatory changes as appropriate
  • Work with Quality, Operations, Engineering, and other
    internal groups to investigate and recommend solutions to address potential
    regulatory issues and impacts
  • Interact and negotiate with regulatory authorities during
    the development (i.e Q-Sub, change notifications, etc.) and submission review
  • Support regulatory agency and/or notified body audits by as
    needed
  • Participate in development and approval of risk activities
    as well as other deliverables as related to medical device projects
  • Review and approve all Labeling (product, advertising and
    promotional) and ensure claims are substantiated
  • Monitor impact of changing evolving global regulations on
    submissions, practices and procedures and communicate to internal stakeholders
  • Support customer inquiry related to compliance issues
  • Comply with Code of Ethics, all Company policies, rules, and
    procedures

Requirements:

  • Bachelor's degree in a Science or Engineering field, or
    equivalent work experience
  • 5+ years of Medical Device Regulatory Affairs experience,
    domestic and international
  • 3 years of experience with Class II or III medical devices
  • Proven history of successful domestic and/or international
    submissions
  • Strong analytical and critical thinking skills
  • Strong verbal and writing communication skills
  • Ability to manage and prioritize multiple projects to meet
    deadlines that align with  company
    objectives
  • Proven track record of working as a team player to overcome
    obstacles and complete tasks through collaboration
  • Proficiency in MS Office software programs
 




Please Login or Register to apply
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