Administrative Staff(with Regulatory Affairs Background – Medical Devices

2 weeks ago

Makati City, National Capital Region, Philippines Towako Repro Bio Cell Inc. (Kato Repro Biotech Center) Full time ₱264,000 - ₱300,000 per year

The Administrative Staff will provide administrative support while assisting in FDA regulatory compliance for medical devices and cosmetic product lines. Responsibilities include coordination of regulatory submissions, document management, and communication with the FDA and suppliers. The role ensures compliance with relevant regulations and supports the preparation of necessary safety and product files.

Key Responsibilities:

  • Provide administrative support to the Regulatory and Quality team.
  • Prepare, organize, and maintain regulatory files (LTO, CMDN, CMDR, CPR, Cosmetic Product Notifications).
  • Coordinate with suppliers and the FDA for document requirements and submissions. Update and monitor product registration databases and timelines.
  • Assist in preparation of Product Information Files (PIF) and safety documentation for cosmetics.
  • Handle internal and external correspondences, filing, and record management.
  • Ensure compliance with FDA, DOH, and ASEAN regulations for medical devices and cosmetics.

Qualifications:

  • Bachelor's Degree in Pharmacy, Chemistry, Biology, Medical Technology, or a related science course.
  • Preferably with a PRC license (Pharmacist or Chemist).
  • At least 1–2 years of experience in regulatory affairs, administration, or a related field.
  • Knowledgeable in FDA processes for Medical Devices (LTO, CMDN, CMDR, CPR) and Cosmetics (Product Notification, PIF).
  • QPIRA Certificate (Medical Devices) with completed QPIRA training.
  • With training in cosmetics regulations or Cosmetic Product Safety Assessment.
  • Organized, detail-oriented, and able to manage multiple document requirements.
  • Good written and verbal communication skills.
  • Proficient in MS Office (Word, Excel, PDF handling).

Job Types: Full-time, Permanent

Pay: Php22, Php25,000.00 per month

Benefits:

  • Additional leave
  • Company Christmas gift
  • Company events
  • Life insurance
  • Opportunities for promotion
  • Paid training
  • Pay raise
  • Promotion to permanent employee

Application Question(s):

  • •Rate is flexible and can be discussed further during the interview.


•Experience handling FDA eServices or online submissions.

•Training in Good Distribution Practice (GDP) or Cosmetic Product Safety Assessment.

•Familiarity with the ASEAN Cosmetic Directive and Medical Device regulations.

Willingness to travel:

  • 25% (Preferred)

Work Location: In person

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