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Regulatory Affairs Specialist
2 months ago
Based in North Cambridgeshire, we are seeking a highly skilled Regulatory Affairs Manager to join our MedTech company focused on the development of IoT medical wearable technology.
This is a unique opportunity to work in a dynamic environment, with the flexibility to work full-time or part-time. The successful candidate will have a strong background in Medical Regulator Approvals within BioTech or MedTech, with experience in Management and internal and regulatory audits.
Key Responsibilities:
- Internal and regulatory audits, including ATEX, FDA, and CE Medical Devices
- Manage the technical file
Requirements:
- Good background in Medical Regulator Approvals within BioTech or MedTech
- Experience in Management and internal and regulatory audits
- Experience with ATEX, FDA, and CE Medical Devices
What We Offer:
- Excellent benefits package
- Bonus scheme
We are an equal opportunities employer and welcome applications from all qualified candidates.