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Medical Device Regulatory Specialist

3 weeks ago

Kuala Lumpur, Kuala Lumpur, Malaysia EPM Scientific - Phaidon International Full time

EPM Scientific - Phaidon International is seeking an experienced Regulatory Affairs Executive to join our team. As a key member of our medical device regulatory team, you will play a critical role in ensuring the quality and safety of our medical devices.

Your Key Responsibilities will be:

  1. To develop and implement effective regulatory strategies to ensure compliance with local and international regulations.
  2. To prepare and submit regulatory documents to relevant authorities.
  3. To monitor and interpret regulatory requirements and communicate changes to the team.
  4. To conduct internal audits and support external audits to ensure compliance with quality standards.
  5. To collaborate with cross-functional teams to address quality and regulatory issues.
  6. To maintain and update quality management systems (QMS) and documentation.
  7. To provide training and support to staff on regulatory and quality assurance matters.

You Will Need:

  • A Bachelor's degree in a related field such as Biomedical Engineering, Life Sciences or Regulatory Affairs.
  • Minimum of 3 years of experience in regulatory affairs and quality assurance within the medical device industry.
  • Strong knowledge of local and international medical device regulations including FDA, CE and ISO 13485.
  • Excellent communication and interpersonal skills.
  • Detail-oriented with strong analytical and problem-solving abilities.
  • Ability to work independently and as part of a team.