Regulatory Compliance Specialist

4 days ago


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

At EPM Scientific - Phaidon International, we're seeking a highly skilled Regulatory Compliance Specialist to join our team.

The successful candidate will be responsible for ensuring that our medical devices comply with all regulatory requirements and maintaining the highest quality standards.

We're looking for someone with strong knowledge of local and international medical device regulations (e.g., FDA, CE, ISO 13485) who can develop and implement regulatory strategies to ensure compliance.

Bachelor's degree in a related field (e.g., Biomedical Engineering, Life Sciences, Regulatory Affairs) is required, along with minimum 3 years of experience in regulatory affairs and quality assurance within the medical device industry.

Excellent communication and interpersonal skills are essential, as you'll be collaborating with cross-functional teams to address quality and regulatory issues.

  • 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.


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