Regulatory Affairs Director

21 hours ago


Subang Jaya, Selangor, Malaysia Monroe Consulting Group Full time

**Job Responsibilities:**

We are seeking a highly experienced Regulatory Affairs Director 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.

  • Direct and coordinate activities necessary to ensure global regulatory compliance with FDA, Canadian, European and other agency regulations.
  • Manage division regulatory activities and serve as the direct liaison with regulatory agencies, as well as with other internal functional departments for new product development strategy.

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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