Regulatory Affairs Director for Medical Devices
vor 1 Tag
Teoxane SA, a leading manufacturer of hyaluronic acid-based dermal fillers and dermocosmetics, is seeking an experienced Regulatory Affairs Director to oversee the management of its EU & US team. The successful candidate will provide leadership and expertise to business partners and stakeholders across multiple functions, including R&D, Clinical, Quality, and Marketing.
Main Responsibilities:- Develop strategic roadmaps aligned with business objectives and provide leadership for pre-market and post-market programs
- Provide mentorship to ensure alignment with business objectives and development plans
- Contribute to key decisions impacting global compliance processes and procedures
- Monitor new EU & US requirements through intelligence gathering and adapt accordingly
- Collaborate with cross-functional teams to develop submissions for new products and product changes
- Oversee the preparation of submission files for new products and product changes to achieve timely submissions/approvals
- Support life-cycle management activities, including change control impact assessments
The ideal candidate will have at least 10 years of experience in regulatory affairs, specifically in high-risk medical devices, with a strong understanding of EU & US regulations. They will be a seasoned leader with excellent analytical thinking and leadership skills, able to resolve problems and make informed decisions.
We are looking for someone who can work effectively in a dynamic environment, collaborating with agencies and Notified Bodies, and handling multiple projects simultaneously. Fluency in English and French is a must.
In addition to their technical expertise, the successful candidate will demonstrate a strong ability to take ownership and responsibility for actions, as well as a commitment to continuous learning and professional development.
Estimated salary: $120,000 - $180,000 per year, depending on experience.
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Regulatory Affairs Director EU
vor 1 Monat
Genf, Genf, Schweiz Teoxane SA VollzeitJob DescriptionTeoxane Laboratories, a leading manufacturer of hyaluronic acid-based dermal fillers and dermocosmetics, is seeking a highly skilled Regulatory Affairs Director EU & US Regions to join our team.This is a key role that will be responsible for managing the EU & US regulatory team dedicated to Innovation & Life-cycle projects. The successful...
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