Aktuelle Jobs im Zusammenhang mit Senior Regulatory Affairs Specialist - Geneva - Michael Page
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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Supply Chain Specialist
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Periodic Review Specialist
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Geneva, Schweiz Lombard Odier VollzeitA career at Lombard Odier means working for a renowned global wealth and asset manager, with a strong focus on sustainable investing. An innovative bank of choice for private and institutional clients, our independently owned Firm is one of the best-capitalised banking groups in the world, managing close to CHF 300 billion and operating from over 25 offices...
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Periodic review specialist
vor 2 Monaten
Geneva, Schweiz Lombard Odier VollzeitA career at Lombard Odier means working for a renowned global wealth and asset manager, with a strong focus on sustainable investing.An innovative bank of choice for private and institutional clients, our independently owned Firm is one of the best-capitalised banking groups in the world, managing close to CHF 300 billion and operating from over 25 offices...
Senior Regulatory Affairs Specialist
vor 4 Monaten
- 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 labeling
- 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
