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Regulatory Compliance Specialist

2 weeks ago

Paranaque City, Calabarzon, Philippines Manpower (Philippines) Full time

Job Overview:

Manpower (Philippines) is seeking a highly skilled Regulatory Compliance Specialist to join our team. As a key member of the quality assurance department, this role will be responsible for ensuring compliance with regulatory requirements and industry standards.

Key Responsibilities:

  • Document and review malfunction MDR data fields and potentially Vigilance Reports as required.
  • Evaluate reportable regulatory decisions to ensure accuracy and document written justification.
  • Perform end-to-end complaint handling activities for Combination Products as requested.
  • Serve as a PQV point person for post-market and complaint handling regulatory questions and inquiries.
  • Collaborate with business partners and stakeholders to drive process improvements and deliver effective change management.

Requirements:

  • 3-5 years of related experience including Quality Assurance and/or Quality Control.
  • Knowledge of medical safety environment and regulation.
  • Bachelor's degree or Master's degree in technical, scientific, or engineering disciplines required.