Regulatory Affairs Specialist
4 hours ago
A medical device company in London is seeking a highly skilled Regulatory Affairs Specialist to support their growth. This role involves managing technical files, dossiers, and regulatory documents for Class 1 Measuring Devices.
Responsibilities include:
- Oversee the development and management of technical files, dossiers, and regulatory documents.
- Collaborate with Notified Bodies to achieve FDA and FDR approval.
- Provide regulatory guidance and ensure compliance with EU regulations.
- Develop and implement EU regulatory strategies to meet product requirements.
Requirements:
- 7+ years of experience in regulatory affairs within a Medical Device business.
- Expert knowledge of MDR, ISO13485, and UK MDR.
- Experience interacting with Notified/Approved Body.
Estimated Salary: £65,000 - £80,000 per annum.
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