Regulatory Affairs Expert

5 days ago


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

About Us

EPM Scientific - Phaidon International is a leading medical device company dedicated to improving healthcare through innovative products. Our commitment to quality and regulatory compliance ensures that our devices meet the highest standards.

Job Description

We are seeking an experienced RAQA Executive to join our team. In this role, you will be responsible for ensuring our medical devices comply with local and international regulations and maintaining quality standards.

Key Responsibilities:

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

Qualifications:

  • Bachelor's degree in a related field (e.g., Biomedical Engineering, Life Sciences, 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 (e.g., FDA, CE, 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.


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