Regulatory Affairs Manager
Location: Gloucester
Employment Type: Permanent, Full-time (Monday - Friday, Hybrid Options Available)
Salary: Competitive, DOE
Overview
Hawk3 Talent Solutions is seeking a Regulatory Affairs Manager to join a manufacturing organization located in Gloucester.
The successful candidate will be responsible for ensuring business compliance with relevant legislation and quality standards to support the company’s overarching objectives of delivering cost-effective, high-quality products while providing exemplary customer service. Key responsibilities include:
- Maintaining current knowledge of both domestic and international regulatory requirements and effectively communicating this information to management and project teams.
- Supporting the processes necessary to ensure that the Quality Management System is upheld in alignment with applicable regulatory and statutory requirements, including ISO 13485, 21 CFR 820, MDD 93/42/EEC, Regulation (EU) 2017/745, and ISO 14971.
- Issuing advisory notices as necessary, in accordance with the MDD, MDR, and FDA regulatory requirements (21 CFR 803).
- Developing, preparing, and maintaining high-quality technical files, design dossiers, and any other required documentation for regulatory submissions and approvals.
Qualifications:
- Proven experience in regulatory affairs, particularly in a managerial capacity.
- Essential experience with medical devices.
- Compl...