Regulatory MGR / Associate Director / Director (Level Dependent Upon Experience)
Purpose: To assure regulatory compliance at Associates of Cape Cod, Inc.
Knowledge and Skill Requirements:
- Knowledge of:
- 21CFR, esp. Parts 210, 211, 600-610, 600’s as appropriate, and 800 as appropriate
- Canadian Medical Device Regulations, SOR/98-282
- Directive 98/79/EC of the European Parliament and of the Council
- FDA Guidance documents, esp. Guideline for Validation of Limulus Amebocyte Lysate Test; Changes to an Approved Application: Biological Products; Sterile Drug Products Produced by Aseptic Processing; Investigating Out-of-Specification (OOS) Test Results
- Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing Current Good Manufacturing Practice (September 2004)
- Guidance for Industry – Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (October 2006)
- Relevant ISO documents, esp. 13485; 14971
- Relevant EU and JP regulations
- Relevant USP chapters
- Good communication and writing skills
- Project management and risk management
- Design control
- At least a Master’s degree and three years’ experience in the regulatory field or an equivalent combination of experience and/or education required
- RAC certification preferred
- Experience on project teams (new product development) with submissions to regulatory bodies
Job Type: Full-time
In your cover letter please answer the following:
- Have you completed the following level of education: Master’s Degree?
- Are you authorized to work in the United States?
- Are you willing to undergo a background check, in accordance with local law/regulations?
Job posted: 2020-12-16