- Provide Regulatory strategies for projects as RA representative in cross-functional teams
- Responsible for regulatory Assessment on product changes
- Coordinate the preparation of regulatory submissions (such as IDE, original PMA and supplements)in the context of new product and product changes in accordance with FDA requirements
- Coordinate the responses to questions raised by FDA
- Review of product labelling
- Participate in audits and inspections, ensuring compliance with FDA requirements
- Stay up-to-date with relevant regulations, guidelines, and industry trends, and provide strategic regulatory guidance to internal stakeholders
- Ensure accurate population of RA databases
- Maintain and update SOP's for Regulatory department
- Minimum 7 to 10 years of experience in Medical device or pharmaceuticals industry
- Proficient knowledge of quality standard (ISO 13485) and relevant regulations (21CFR part 820, MDR 2017 / 745) and appropriate laws, guidelines and industry standards Demonstrated experience in communicating with regulatory agencies including FDA and UE regulatory agencies
- Demonstrated experience in leading, writing and submission of complex regulatory filling(e.g. IDE, PMA, CE mark, etc )
- Demonstrated ability in analytical reasoning and critical thinking skills
- Good knowledge of relevant regulations (FDA)
- Ability to work on several projects simultaneously, ability to prioritize
- Fluent in English with at least a B2 level in French
9 giorni fa