Biologics, Manufacturing & Distribution, Quality/Risk Management, US Regulatory Affairs
You will be responsible for assuring regulatory compliance at Associates of Cape Cod, Inc. Relocation assistance may be available for qualified individuals. Knowledge, experience and skills requirements include the following:
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
A minimum of a Masters 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.
Internal Number: RA-01
Associates of Cape Cod, Inc. specializes and is a major manufacturer of products specifically for endotoxin and glucan detection and removal.