Job Opening – Regulatory Affairs Associate I or II

BioFire Defense is an Equal Opportunity Employer (M/F/D/V).

Position

Regulatory Affairs Associate I or II Posted: 3/22/2021

Status

Department

Full-Time Regulated Products

Position Summary:

The Regulatory Affairs Associate will assist the Regulatory Affairs team with formatting, assembling, and timely preparation of documents for domestic and international regulatory submissions and ensuring compliance with applicable regulations. The Regulatory Affairs Associate will support review of labeling and marketing materials for regulatory compliance; familiarity with FDA, Health Canada, IVDD, IVDR, ISO, OSHA, RoHS, REACH, UL, GMP, UDI, and ISO13485/9001 requirements is desired, but may be learned on the job. The Regulatory Affairs Associate will support Quality System compliance for the Regulated Products group, including writing and revising relevant SOPs/WIDs, design document review, and constructively implementing compliance mechanisms for new regulations and regulatory guidance. The Regulatory Affairs Associate will also assist with post-market activities including post-market surveillance, adverse event reporting, and field actions. Collaboration with personnel in multiple company departments is required to understand the products and maintain/implement new policies/procedures. Must be available for on-site audits, and to perform both on and off-Site audits.

Training and Education:

  • BA/BS in Science preferred

Experience:

  • BA/BS in Science (e.g., molecular biology, microbiology, chemistry, biology) preferred, regulatory experience desired.
  • Excellent technical writing, attention to detail, and proficiency with Microsoft products are essential skills.

Benefits and Compensation:

  • We offer competitive salaries
  • 401k
  • Vacation/holiday pay
  • Medical benefits
  • Stimulating work environment

If you are interested in this position please send us your resume and contact details through one of our job boards at:

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Our EEO Policy

BioFire Defense is an equal opportunity employer (M/F/D/V). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.