Senior Product Compliance Analyst

Description

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

Job Posting

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