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| Job Location | Cambridge |
| Education | Not Mentioned |
| Salary | Competitive salary |
| Industry | Not Mentioned |
| Functional Area | Not Mentioned |
| Job Type | Permanent , full-time |
14 September 2023 Permanent Full Time EmployersJob Title: Director of Regulatory Affairs - Medical DevicesLocation: CambridgeshireOverview:A leading innovator in the field of medical devices, committed to enhancing the lives of patients globally. They are currently seeking a highly skilled Directorof Regulatory Affairs to join their Cambridgeshire team. The Director of Regulatory Affairs will be responsible for ensuring their range of Medical Device products continue to meet regulatory requirements. Director of Regulatory Affairs - Key Responsibilities:Developand execute comprehensive regulatory strategies to ensure compliance with relevant regulations and standards; ISO 13485, IEC 60601 and IEC 62304.Keep abreast of evolving global regulatory requirements and communicate their impact on the companys productsand strategies.Oversee the preparation and submission of regulatory applicationsManage interactions with regulatory agencies and notified bodies, ensuring successful approvals and clearances.Develop and maintain processes for post-market surveillance, adverseevent reporting, and product recalls.Implement strategies for product lifecycle management, including updates, renewals, and discontinuations.Director of Regulatory Affairs - Qualifications:7+ years of medical device regulatory experience.Expertise inISO 13485, IEC 60601 and IEC 62304 standards.Prior team management experience.Strong grasp of EU MDR, FDA, and global regulatory requirements.Exceptional communication and negotiation skills.Strategic thinking and decision-making in complex regulatoryscenarios.Experience with pre-market and post-market regulatory activities.If you are an experienced Regulatory Affairs professional within the Medical Device industry and ready for a move, do not hesitate to reach out to Julie Harding at X4 Life Sciencesto discuss further #J-18808-Ljbffr