Knowledge: In-depth understanding of medical device regulations (e.g., ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU...
Practice (GCP) and/or regulatory compliance guidelines for real-world evidence studies or clinical trials (e.g., ISO, MDD/MDR...
such as QSRs, FDA, ISO, MDD and other applicable regulations. Experience and understanding Process Validations (IQ, OQ, PQ), 6S...
). Minimum of 3 years of experience in quality and risk management in a highly regulated industry. Familiarity with FDA, ISO, MDD...
, ISO14971, IEC62304), regulations (e.g. 21 CFR Part 820, 21 CFR Part 11, European Union Medical Device Directive (MDD)/ Medical... 13485, ISO 14971, 21 CFR 820, IEC 60601-1, MDD/MDR, and IEC 62304, FDA’s General Principles of Software validation...
analysis using tools such as Matlab and Minitab Optical design (ZEMAX preferred) Knowledge of ISO, FDA, MDD and regulations...
, including but not limited to U.S. FDA, EU MDD/MDR, ISO 13485, Health Canada, MHLW, ANVISA, and TGA. Experience in supporting...
of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other applicable regulations...
required to participate in the Material Development Decision (MDD), the pre-/post-Acquisition Strategy Panel (ASP), source selection activity...
(e.g., ISO, MDD/MDR, CFR), and prior experience in FDA and/or global regulatory submissions. The salary...