![Michael Page](https://media.trabajo.org/img/noimg.jpg)
Senior Regulatory Affairs Specialist
vor 4 Wochen
- 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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Regulatory affairs specialist
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Regulatory affairs specialist
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Geneva, Schweiz Albedis VollzeitINTRODUCTION: For one of our client in the consumer health industry, we are looking to hire a candidate strongly interested in Regulatory Affairs, with experience in medicinal products.DESCRIPTION DE LA MISSION: As the Regulatory Affairs Specialist, you will play a critical role in enabling the PHC business for the relevant portfolio within and outside...
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Head of Regulatory Affairs
vor 4 Wochen
Geneva, Schweiz Michael Page VollzeitMentor, train, and supervise Regulatory Affairs teams, ensuring effective collaboration with other departments.Monitor and interpret changes in international regulations.Develop and implement regulatory strategy aligned with the company's business objectives, in collaboration with other departments.Supervise the preparation and submission of registration...
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