Senior Regulatory Affairs Specialist

Gefunden in: Talent CH A C2 - vor 1 Woche


Geneva, Schweiz Michael Page Vollzeit
  • 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

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