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Medical Device Regulatory Affairs Expert

1 week ago

Kuala Lumpur, Kuala Lumpur, Malaysia Barrington James Full time

Barrington James is a dynamic and innovative medical device company seeking a highly skilled Regulatory Affairs Specialist to serve as the subject matter expert on regulatory requirements and strategies in Indonesia, with the potential to support other Southeast Asian countries.

This key role will be responsible for managing daily operations of regulatory affairs, ensuring regulatory compliance, and securing necessary approvals from government agencies for commercial distribution of medical devices. The Regulatory Affairs Specialist will also handle product change assessments, manage product complaints, oversee adverse event reporting, and coordinate required product recalls.

**Key Responsibilities:**

  • Manage regulatory affairs activities to ensure compliance with relevant laws and regulations
  • Secure necessary approvals from government agencies for commercial distribution of medical devices
  • Handle product change assessments, manage product complaints, and oversee adverse event reporting
  • Coordinate required product recalls and ensure timely resolution of issues

**Requirements:**

  • 4-8 years of experience in the medical device industry, with at least 5 years in regulatory affairs

**What We Offer:**

We offer a challenging and rewarding career opportunity for a regulatory affairs professional passionate about ensuring compliance and contributing to the launch of new medical solutions. If you are ready to make an impact in the field of regulatory affairs, please apply for a detailed discussion on this job role.