Medical Device Regulatory Strategist

14 hours ago


Subang Jaya, Selangor, Malaysia Monroe Consulting Group Full time

**Job Summary:**

We are seeking an experienced Medical Device Regulatory Strategist to join our team. The ideal candidate will have a strong background in regulatory affairs and experience in dealing with FDA, Notified Bodies, and other regulatory agencies.

The successful candidate will be responsible for leading the development and implementation of regulatory strategies to support business objectives while ensuring global regulatory compliance with FDA, Canadian, European and other agency regulations.

  • Develop and maintain relationships with regulatory agencies, such as FDA, Notified Bodies, and other international regulatory bodies.
  • Oversee existing division products and obtain marketing approval for new/modified device applications.

The ideal candidate should possess a Bachelor's degree in biological sciences, microbiology, chemistry or engineering, and RAC certification is highly desirable. 5+ years' experience in regulatory affairs in a medical device company is required.



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