Legislative Affairs Professional

2 weeks ago


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

The successful Regulatory Affairs Manager will be responsible for maintaining current knowledge of domestic and international regulatory requirements and effectively communicating this information to management and project teams.

You will also be responsible for 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.

In addition, you will be required to issue advisory notices as necessary, in accordance with the MDD, MDR, and FDA regulatory requirements (21 CFR 803).



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