Regulatory Affairs Executive

1. Preparation of documentation for submission to FDA for medical device approval and/or response to FDA inquiries
2. Responsible for Compliance of Medical Device Directive (MDD) 93/42/EEC, ISO 13485:2016, ISO14971:2012 & Medical device Rules 2017.
3. Demonstrated success in a start-up, entrepreneurial work environment
4. Thorough knowledge of FDA Quality System requirements, ISO 13485:2012 (Quality System) requirements, ISO 14971 (Risk Management) requirements, Medical Device Directives (MDD) requirements, Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards