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Regulatory Affairs Director for Medical Device Industry

1 month ago

Oxford, Oxfordshire, United Kingdom Lenntech Search Full time

LennTech Search is a recruitment agency working with innovative software medical device companies. We have an exciting opportunity for an experienced Regulatory Affairs Manager to join our client's team.

Key Responsibilities
  • Lead the company's regulatory submissions to the FDA, ensuring compliance with all relevant regulations and guidelines.
  • Prepare and submit applications and reports to applicable regulatory agencies, such as the US FDA, Canadian authorities, and Chinese regulatory bodies.
  • Respond to reviews and requests for information from regulatory bodies, effectively communicating with stakeholders to resolve any issues.
  • Oversee vigilance and regulatory authority reporting activities, maintaining accurate records and ensuring timely submission of reports.
Required Skills and Qualifications
  • Proven experience in developing software medical devices, including AI-based solutions.
  • Detailed knowledge of medical device regulatory requirements in the US, Canada, and China, with the ability to adapt to changing regulations.
Estimated Salary: $120,000 - $180,000 per year

The estimated salary range is based on industry standards and takes into account the level of experience and qualifications required for this role. Our client offers a competitive compensation package, which includes a base salary, bonuses, and benefits.