Medical Device Compliance Manager
1 day ago
X4 Life Sciences, a London-based start-up, seeks an experienced Regulatory Affairs Manager to join their team. As a key member of the organization, you will be responsible for developing and implementing regulatory strategies to bring innovative medical devices to market.
Key Responsibilities include:
- Developing and managing technical files, dossiers, and regulatory documents.
- Working closely with cross-functional teams to achieve regulatory approvals.
- Providing expert guidance on EU regulations and ensuring compliance.
About You:
- 7+ years of experience in regulatory affairs, preferably within the Medical Device industry.
- Proven track record of delivering regulatory projects on time and budget.
- Strong knowledge of EU regulations, including MDR and ISO13485.
Benefits:
- Ongoing training and professional development opportunities.
- Bonus scheme based on performance.
- Flexible working hours and remote work options.
Salary: £70,000 - £90,000 per annum
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