Aktuelle Jobs im Zusammenhang mit Senior Regulatory Affairs Specialist - Genf, Genf - Michael Page

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    vor 3 Wochen

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    vor 2 Wochen

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    vor 3 Wochen

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  • Regulatory Affairs Manager

    vor 2 Wochen

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    Vor 5 Tagen

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    {"h1": "Regulatory Affairs Officer (Asia) at Teoxane SA", "p": "We are seeking a highly skilled Regulatory Affairs Officer to join our team in Asia. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with regulatory requirements for medical devices in Asian countries.", "ul": [{"li": "Prepare and write...

  • Regulatory Affairs Specialist

    vor 3 Wochen

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    Vor 6 Tagen

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    vor 3 Wochen

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    vor 3 Wochen

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    vor 1 Woche

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    vor 2 Wochen

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    Vor 5 Tagen

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    vor 3 Wochen

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    Genf, Genf, Schweiz SYZ SA Vollzeit

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    vor 1 Woche

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Senior Regulatory Affairs Specialist

vor 3 Monaten

Genf, Genf, 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 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