Position Summary:
- The Regulatory Affairs Associate or Specialist 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. Proficiency in technical writing is required. The RA Associate or Specialist 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 RA Associate or Specialist will also assist with post-market activities including post-market surveillance, adverse event reporting, and field actions. The RA Associate or Specialist 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. Collaboration with personnel in multiple company departments is required to understand the products and maintain/implement new policies/procedures. Candidates will possess independent work habits, strong organizational skills, enhanced attention to detail, diplomacy, and extensive written and verbal communication skills.
Training and Education:
- Bachelor’s Degree required.
- Proficiency with Microsoft Office including Excel, Work, and OneNote required.
- Extensive technical writing experience, organizational skills, and communication proficiency required.
- Experience working in highly regulated environments (FDA, ISO) experience a plus.
- 2+ years of experience in technical writing, quality assurance, or regulatory setting preferred for Specialist position.
Experience:
- BA/BS in science (e.g., molecular biology, microbiology, chemistry, biology) preferred.
- Regulatory experience required for Specialist position.
Benefits and Compensation:
- We offer competitive salaries
- 401k
- Vacation/holiday pay
- Medical benefits
- Stimulating work environment
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