in a life science or technical discipline, preferably in engineering, bioengineering, biology, or chemistry. 2-5 years...
Job Description: Computerized Systems Validation (CSV) position involves ensuring that GxP-regulated computer systems and software comply with current Good Manufacturing Practices (cGMP) regulations, international guidelines (like 21 CFR P...
Responsibilities: The Regulatory Affairs Associate, with minimal guidance prepares, reviews and submits high quality annual reports with FDA within Annual report timelines and in accordance with regulatory guidelines and applicable federa...
Responsibilities: Autonomously support new product development core teams including development of regulatory strategies and the preparation of regulatory content for domestic and international submissions for IVD medical devices to suppo...