Senior Regulatory Affairs Leader, Medical Devices in Cambridge

Senior Regulatory Affairs Leader, Medical Devices in Cambridge

Cambridge Full-Time 60000 - 80000 Β£ / year (est.) No working from home possible
Endomag DE

At a Glance

  • Tasks: Lead regulatory strategy and submissions for medical devices, ensuring compliance with FDA/ISO.
  • Company: Endomag, a Hologic company, known for innovation in medical technology.
  • Benefits: Competitive salary, career development opportunities, and a supportive team environment.
  • Other info: Join a dynamic team in a fast-paced, innovative environment.
  • Why this job: Shape the future of medical devices and make a real difference in patient care.
  • Qualifications: Experience in regulatory affairs and strong leadership skills required.

The predicted salary is between 60000 - 80000 Β£ per year.

Endomag, a Hologic company, seeks a Senior Manager, Regulatory Affairs to lead the Regulatory function at its Cambridge site.

You will shape regulatory strategy for development and lifecycle management, driving submissions and liaising with authorities to enable timely approvals.

You will mentor the regulatory team, align priorities with business goals, and ensure compliance with FDA/ISO requirements across US and EU, while supporting new product development and lifecycle activities.

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Senior Regulatory Affairs Leader, Medical Devices in Cambridge employer: Endomag DE

Endomag, a Hologic company, is an exceptional employer that fosters a collaborative and innovative work culture at its Cambridge site. Employees benefit from comprehensive professional development opportunities, mentorship from experienced leaders, and the chance to make a significant impact in the medical devices sector. With a strong commitment to compliance and quality, Endomag not only supports career growth but also prioritises employee well-being and engagement, making it a rewarding place to work.

Endomag DE

Contact Details:

Endomag DE Recruitment Team

We think you need these skills to ace Senior Regulatory Affairs Leader, Medical Devices in Cambridge

Regulatory Strategy Development
Submission Management
Liaising with Regulatory Authorities
FDA Compliance
ISO Compliance
Team Mentoring
Business Goal Alignment