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

Position

Regulatory Affairs Associate
Posted: 12/03/2018

Status

Department

Full-Time Regulated Affairs Associate

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, post-market surveillance of regulated products and constructively implementing compliance mechanisms for new regulations and regulatory guidance. Collaboration with personnel in multiple company departments is required to understand the products and maintain/implement new policies/procedures.

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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