Senior Regulatory Affairs Specialist (FDA experience mandatory)

• 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

Michael Page