Regulatory Affairs Manager

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.
- Completion of Lead Auditor training.
- Strongly desirable experience with MDR




Benefits :
 
25 days’ holidays plus bank holidays
Pension - Nest
Single Vitality Healthcare – upon successful completion of the probationary period
Perkbox
 
Hawk 3 Talent Solutions are operating as an employment agency on behalf of its client.
To Apply please follow the application process for the site this job is advertised on or email your CV to  (url removed). By applying for the above position and providing your personal data to us you understand that your data will be processed in line with our Privacy Policy. To view our full Privacy Policy please visit our website.
Hawk 3 Talent Solutions are committed to the selection, recruitment and development of the best people, basing judgements solely on suitability for the job. Whilst we endeavour to respond to all applications individually, due to high volumes, this is not always possible. Thank you for your interest in this role and we look forward to working with you in the future