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Regulatory Compliance Manager

2 weeks ago

Makati City, National Capital Region, Philippines Somnomed Philippines Inc. Full time
Job Overview

Somnomed Philippines Inc. is a leading company in the medical device industry, and we are seeking a highly skilled Regulatory Compliance Manager to join our team. This role plays a crucial part in ensuring the quality and regulatory compliance of our products.

About the Role
  • The successful candidate will be responsible for managing various tasks related to quality assurance, including drafting quality documentations, reporting detected areas of risk, and communicating with internal stakeholders to ensure quality awareness and regulatory compliance.
  • This role requires strong analytical and problem-solving skills, as well as excellent documentation and communication skills.
  • The ideal candidate should have a broad understanding of ISO 9001 and knowledge of relevant regulations such as US FDA 21 CFR 820 Quality Systems Regulation.
Responsibilities
  • Manage controlled documents and maintain records. Responsible for upkeep of documents and records master list, including those of external origin.
  • Maintain site master file.
  • Prepare and conduct quality-related trainings to all SPI employees.
  • Support the lead and coordinator during certification audits, regulatory inspections, and other external audits.
  • Participate in internal audits and quality walkthroughs. May help prepare audit plans, audit program, audit checklists, organizes necessary meetings, and raise related NCs.
Requirements
  • Bachelor's Degree in Life Sciences or Scientific Engineering is required.
  • 3-5 years of collective experience in manufacturing quality control and assurance is required, preferably in medical device or pharmaceutical industry.
  • Broad understanding of ISO 9001 is required. Understanding of ISO 13485 is desirable.
  • Knowledge of US FDA 21 CFR 820 Quality Systems Regulation, EU Medical Device Regulation, and other regional quality regulations is preferred.
  • Excellent documentation and communication skills are required.
  • Proficiency in Microsoft Office is required.