Compliance and Regulatory Lead

6 days ago


Gloucester, Gloucestershire, United Kingdom Omega Full time

Job Overview:

We are seeking a highly experienced Regulatory Affairs Manager to join our client, a global leader in the medical device industry. The successful candidate will play a critical role in ensuring compliance with regulatory requirements and maintaining the company's reputation for quality and excellence.

About the Job:

  • The Regulatory Affairs Manager will be responsible for ensuring business compliance with domestic and international regulatory requirements;
  • Maintaining up-to-date knowledge on regulatory requirements and communicating effectively with management and project teams;
  • Supporting the process to ensure the Quality Management System is maintained in accordance with relevant regulatory/statutory requirements;
  • Developing, preparing, and maintaining high-quality technical files, design dossiers, and other necessary applications for regulatory submissions and approvals.

Requirements:

  • Proven experience within regulatory affairs with extensive experience in a managerial position;
  • Medical Device experience is essential;
  • Lead Auditor training;
  • MDR experience is strongly desirable.

What You'll Get:

  • 25 days annual leave + Bank Holidays;
  • Private Health Care Options;
  • Employee Assistance Programmes;
  • Competitive Pension Scheme.

Candidates who currently hold a similar role may be suitable for this position.



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