Medical Device Regulations Expert
3 weeks ago
We are looking for a highly skilled Regulatory Affairs Manager to join our team at Omega Resource Group.
The successful candidate will have extensive experience in regulatory affairs, with a strong background in medical devices and quality management systems.
As a key member of our team, you will be responsible for maintaining regulatory compliance and ensuring market access for medical devices internationally.
Responsibilities:
- Maintaining up-to-date knowledge of domestic and international regulatory requirements.
- Supporting the maintenance of the Quality Management System in accordance with relevant regulations.
- Issuing advisory notices as required, adhering to MDD, MDR, and FDA regulatory requirements.
- Developing high-quality technical files, design dossiers, and other necessary applications for regulatory submissions and approvals.
Requirements:
- Proven experience in regulatory affairs, preferably in a managerial position.
- Essential medical device experience, with Lead Auditor training and MDR experience desirable.
Estimated Salary: £70,000 - £90,000 per annum, depending on experience.
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