Medical Device Compliance Manager

1 day ago


London, Greater London, United Kingdom X4 Life Sciences Full time
Regulatory Affairs Manager Job

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:
  1. Developing and managing technical files, dossiers, and regulatory documents.
  2. Working closely with cross-functional teams to achieve regulatory approvals.
  3. 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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