Regulatory Compliance Manager

7 days ago


Manila, National Capital Region, Philippines MEDEV Medical Devices Corporation Full time
About the Position

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at MEDEV Medical Devices Corporation. As a key member of our regulatory department, you will play a crucial role in ensuring our medical devices comply with relevant regulatory standards and requirements.

This is a full-time position offering the opportunity to develop your expertise in an innovative and rapidly growing company.

Responsibilities:
  • Assist the Regulatory Affairs Officer in ensuring compliance with regulatory requirements.
  • Conduct research on regulatory requirements for medical equipment in the Philippines.
  • Apply regulatory guidelines to product importation, sales, and marketing processes.
  • Prepare regulatory documentation, including technical files, for product clearance and approval.
  • Collaborate with internal teams to gather necessary data and information for regulatory submissions.
  • Coordinate with regulatory authorities and notified bodies during the approval process.
  • Stay up-to-date with changes in regulations and industry standards.
  • Conduct internal audits to ensure compliance with regulatory standards.
  • Support post-market surveillance activities.
  • Participate in the development of regulatory processes and procedures.


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