Associate Director, Regulatory Affairs
6 days ago
Job Title: Associate Director, Regulatory Affairs - Medical Devices
Job Type: Full Time, Permanent Position
Location: Greater London, UK and some EU locations
Remuneration: Attractive salary and package
An exciting opportunity to join a growing pharmaceutical company that specializes in Cancer and Supportive Care, Gastroenterology, and Hepatology. Due to increasing growth, the business is looking for an Associate Director, Regulatory Affairs Medical Devices Lifecycle Management to join the team.
As an Associate Director, Regulatory Affairs - Medical Devices Lifecycle Management, you will be responsible for the strategic lifecycle management of the business's Medical Devices post CE approval and the operational execution management with the Regulatory Service Provider. This includes the responsibility and oversight of all activities required for the successful and smooth integration of new products following launch and all associated ongoing regulatory maintenance activities.
Main Responsibilities:
- To be the primary regulatory point of contact for all medical device queries for the business's portfolio by providing guidance on regulatory medical device requirements and compliance to brand teams and other areas of the business.
- Inputting into discussions on projects and questions associated with medical devices, anticipating and resolving complex regulatory issues associated with medical devices.
- Lead and support all post-market surveillance activities for the medical device portfolio in the UK, Europe, and growth regions.
- Drive all Regulatory Affairs Medical Device strategies for global regions.
- Responsible for NPD activities for devices.
- To oversee, manage, and where required advise the Regulatory Service Provider on medical device maintenance and submission strategies, plans, and the preparation of updates to the technical file and regulatory submissions for all medical device-related changes.
- The preparation of high-quality documentation for labeling regulatory submissions, following current best practice.
- To represent Regulatory Affairs Lifecycle Management – Medical Devices internally and externally.
- To maintain up-to-date knowledge of relevant regulations, guidelines, and industry standards and apply in practice through procedures, knowledge sharing, and advice to project teams.
- To manage regulatory intelligence information for medical devices, including databases (e.g., NOTIS).
- To coordinate QMS-related regulatory activities e.g., deviations and CAPAs as applicable.
Requirements:
- BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
- Previous experience in Regulatory Affairs is a MUST
- At least 8 years + experience within the medical device sector and have a sound understanding of new registrations and post-market surveillance activities.
- Confident with maintaining medical devices in global regions.
- Broad regulatory medical device experience, part of which should have been gained operating at a senior level, and good knowledge of worldwide regulatory requirements (including GMP, GLP, and BCP).
- Must have expertise in the development, certification, and maintenance of medical device products.
- Line management or staff oversight/coaching experience.
- Experience managing Service Providers is essential.
This role allows the right person to step into a senior role within the business and take responsibility for a growing portfolio of medical devices. Due to the business's continuous growth, this person will have an excellent opportunity to grow and develop. The position also comes with an attractive salary and package.
For more information regarding this role, please reach out to lucy.kirkaldy@cpl.com
Please note you must have the full right to work, and this employer doesn’t offer sponsorship.
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