Regulatory Affairs Director

4 days ago


Gloucester, Gloucestershire, United Kingdom Omega Resource Group Full time

Job Title: Regulatory Affairs Manager

Job Summary:

Omega Resource Group is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key member of our team, you will be responsible for ensuring business compliance, regulations, and quality standards in support of our client's goals.

Key Responsibilities:

  • Maintain up-to-date knowledge on domestic and international 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.

Requirements:

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

Benefits:

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

Candidates who currently hold a Regulatory Affairs Manager, Compliance & Regulatory Affairs Manager, Regulatory Affairs Director, or Regulatory Affairs Specialist position may be suitable for this role.



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