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Regulatory Affairs Director
4 weeks ago
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.
