Regulatory Affairs Manager

Regulatory Affairs Manager

Location: Gloucester

Permanent: Full time Monday -Friday (Hybrid Options Available)

Salary:  Competitive, depending on experience

 

 

Overview

Hawk3 talent solutions are recruiting for a Regulatory Affairs Manager to join a manufacturing company at their site based in Gloucester

 

To ensure business compliance to legislation and quality standards in support of the company's overall goals for the delivery of cost effective, high quality products and excellent customer service

- Maintain up-to-date knowledge on both domestic and International Regulatory requirements, effectively communicating to management and project teams.

- Support the process to ensure the Quality Management System is maintained in accordance with relevant regulatory/statutory requirements (including ISO13485, 21 CFR 820, MDD 93/42/EEC, Regulation (EU) 2017/745 and ISO14971)

- Issues advisory notices as required, in accordance to the MDD, MDR, and FDA regulatory requirements (21 CFR 803)

- Develop, prepare, and maintain high quality technical files, design dossiers and other necessary applications for regulatory submissions and approvals

Qualifications:

- Proven experience within regulatory affairs with an extensive amount being in a managerial position

- Medical Device experience is essential

- Lead Auditor training

- MDR experience strongly desirable

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  Maria.Thorne@hawk-3.com. 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