regulatory affairs specialist

2 weeks ago


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

About the role

We are looking for a Regulatory Affairs Specialist to join our team at MEDEV Medical Devices Corporation in Paranaque City, Metro Manila. As a Regulatory Affairs Specialist, 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.

What you'll be doing

  1. Assist the Regulatory Affairs Officer in making sure the company is able to abide by all legal requirements to operate and sell its products and services in the Philippines.
  2. Conduct comprehensive research on existing and upcoming regulatory requirements for medical equipment in the country.
  3. Interpret and apply regulatory guidelines to product importation, sales and marketing processes.
  4. Prepare and submit regulatory documentation, including technical files as required for product clearance and approval.
  5. Collaborate with foreign suppliers, manufacturers and internal teams to gather the necessary data and information for regulatory submissions.
  6. Coordinate with regulatory authorities and notified bodies during the approval process, responding to any inquiries or additional requests.
  7. Stay up-to-date with changes in regulations and industry standards, advising the organization on potential impacts and necessary adjustments.
  8. Conduct internal audits to ensure compliance with regulatory standards and address any non-conformities.
  9. Support post-market surveillance activities, including adverse event reporting and product recalls, if necessary.
  10. Participate in the development and improvement of regulatory processes and procedures within the organization.

What we're looking for

  1. Bachelor's degree in a related scientific or engineering field (e.g., Pharmacy, Engineering, etc.).
  2. Strong analytical skills and attention to detail to ensure accuracy and compliance in all regulatory documents.
  3. Excellent verbal/written communication and interpersonal skills to collaborate effectively with foreign suppliers, cross-functional teams and regulatory authorities.
  4. Ability to manage multiple projects and prioritize tasks in a fast-paced environment.

What we offer

At MEDEV Medical Devices Corporation, we are committed to providing a supportive and rewarding work environment. As a Regulatory Affairs Specialist, you will have the opportunity to contribute to the development and success of our innovative medical devices. We offer competitive compensation, comprehensive health and wellness benefits, and opportunities for professional development and career advancement. Join our team and be a part of our mission to improve patient outcomes and enhance the quality of healthcare.

Apply now to become our next Regulatory Affairs Specialist and be a part of our growing team at MEDEV Medical Devices Corporation.

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