Medical Device Regulations Specialist

21 hours ago


Gloucester, Gloucestershire, United Kingdom Omega Full time

Join Our Client's Team:

We are seeking a highly skilled Regulatory Affairs Manager to join our client, a global leading manufacturer in the medical device industry. As a key member of the team, you will play a crucial role in ensuring business compliance, regulations, and quality standards.

About the Role:

  • Ensure business compliance with domestic and international regulatory requirements;
  • Maintain up-to-date knowledge on regulatory requirements and effectively communicate to management and project teams;
  • Support the process to ensure the Quality Management System is maintained in accordance with relevant regulatory/statutory requirements;
  • Develop, prepare, and maintain high-quality technical files, design dossiers, and other necessary applications for regulatory submissions and approvals.

Benefits:

  • 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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