Regulatory Affairs Director

3 weeks ago


Gloucester, Gloucestershire, United Kingdom Hawk 3 Talent Solutions Full time

Join Hawk3 Talent Solutions in Gloucester as a Regulatory Affairs Manager and contribute to the success of our manufacturing organization.

We offer a competitive salary of £60,000 - £80,000 per annum, depending on experience, and a range of benefits including 25 days' holiday plus bank holidays, pension scheme, and more.

The successful candidate will be responsible for ensuring business compliance with relevant legislation and quality standards to support our company's objectives. Key responsibilities include:

Staying up-to-date with domestic and international regulatory requirements and effectively communicating this information to management and project teams.

Supporting processes necessary to maintain our Quality Management System 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 MDD, MDR, and FDA regulatory requirements (21 CFR 803).

Developing, preparing, and maintaining high-quality technical files, design dossiers, and 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.

This role offers an excellent opportunity for career growth and development in a dynamic and supportive environment.



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