Regulatory Affairs Manager in Long Island City, New York at AccruePartners

Date Posted: 10/23/2019

Job Snapshot

Job Description

THE TEAM YOU WILL BE JOINING:

  • Established, global leader in its industry with over 100 year history specializing in advanced products and R&D
  • Operates in over 25 locations worldwide with revenues in excess of $4B
  • Innovative organization that is highly regarded in its industry

WHAT THEY OFFER YOU:

  • Company offers competitive compensation, a comprehensive benefits package, and opportunities for cross-functional involvement partnering with all aspects of the business.
  • Great company culture and people-focused environment.
  • Company offers great advancement opportunities.
  • Company also offers employee education assistance.

WHY THIS ROLE IS IMPORTANT:

Product Regulatory Compliance

  • Lead teams in the preparation of documents and records necessary for regulatory compliance (FDA, CE, EU, MDR, Health Canada) including risk analysis, MDR general safety and performance requirements, MDR classification, Device Master Records, Technical File, Declaration of Conformity, Clinical Evaluation, etc. 
  • Manage/support organizational and product registrations and listings including FDA Device Establishment Registration, FDA product listings, Health Canada Device Licensing, EU MDR product lists.
  • Prepare FDA 510K pre-market clearance applications for new or revised products.
  • Support international partners with the registration of medical devices.
  • Interact with Notified Body during evaluations of Technical Files.
  • Prepare and submit vigilance reports for mandatory reporting incidents.

Product Safety and Testing

  • Oversee third party product testing to applicable device standards (IEC 60601 series).
  • Maintain North American NRTL safety mark by assuring appropriate production testing, and verifying use of critical components.  Coordinate factory inspections by NRTL inspectors.
  • Support QA Engineers and Product development teams in assuring compliance with standards and directives as applicable which may include RoHS, WEEE, Software Development EN 62304, and Wireless Communications standards.

Quality System Certification

  • Represent the organization during third-party Quality Management System audits.
  • Respond to audit findings and implement corrective actions.

Internal Audits

  • Assist in the planning and coordination of internal audits.  Perform audits of quality system processes.

Product Development

  • Participate on product development teams to assure that regulatory needs are being met.
  • Provide input to and review/approve requirements specifications, verification test plans, validation test plans, product transfer/release documentation.

THE BACKGROUND THAT FITS:

  • Bachelors degree in Engineering (mechanical, electrical, biomedical, plastics, chemical)
  • 6-10 years of relevant work experience
  • Proficient knowledge of all regulatory FDA, CE, EU, MDR, Health Canada and policies including ISO 13485 and IEC 60601
  • Must have experience with regulatory submissions

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