Regulatory Compliance Specialist

20 hours ago


Subang Jaya, Selangor, Malaysia Monroe Consulting Group Full time

**Job Description:**

We are seeking a seasoned Regulatory Compliance Specialist to join our team. The ideal candidate will have extensive experience in regulatory affairs within the medical device industry.

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.
  • Assist the research and development team during new product development and design control processes.
  • Provide global regulatory assessments and pathways for new product development.

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. Experience in dealing with FDA, Notified Bodies, and other regulatory agencies is essential.



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