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Regulatory Affairs Executive Lead

3 weeks ago

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

Job Title: Regulatory Affairs Executive

About Us:

  • EPM Scientific - Phaidon International is a leading medical device recruitment agency dedicated to improving healthcare through innovative medical devices.

We are seeking a highly motivated and detail-oriented Regulatory Affairs Executive to join our team. In this role, you will be responsible for ensuring that our medical devices comply with all regulatory requirements and maintaining the highest quality standards.

Key Responsibilities:

  1. Develop and implement regulatory strategies to ensure compliance with local and international regulations.
  2. Prepare and submit regulatory documents to relevant authorities.
  3. Monitor and interpret regulatory requirements and communicate changes to the team.
  4. Conduct internal audits and support external audits to ensure compliance with quality standards.
  5. Collaborate with cross-functional teams to address quality and regulatory issues.
  6. Maintain and update quality management systems (QMS) and documentation.
  7. Provide training and support to staff on regulatory and quality assurance matters.

Qualifications:

  • 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.