Regulatory Affairs Professional
3 days ago
About the Role
Hawk 3 Talent Solutions is seeking an experienced Regulatory Affairs Professional to join a leading manufacturing organization in Gloucester. The successful candidate will play a crucial role in ensuring business compliance with relevant legislation and quality standards, supporting the company's objectives of delivering cost-effective, high-quality products while providing exceptional customer service.
The estimated salary for this position is around £50,000-£60,000 per annum, depending on experience.
Key Responsibilities
- Maintaining up-to-date knowledge of domestic and international regulatory requirements and effectively communicating this information to management and project teams.
- Supporting 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 and Experience
- 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.
About Us
Hawk 3 Talent Solutions operates as an employment agency on behalf of its client. As a reputable recruitment agency, we strive to provide exceptional service to both our clients and candidates.
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