Senior Regulatory Compliance Specialist

2 days ago


Singapore beBeeRegulatory Full time $80,000 - $100,000
Quality Assurance Manager

The Quality Assurance Manager will play a pivotal role in ensuring the organization's quality management system (QMS) is compliant with regulatory standards. This includes implementing and maintaining processes to meet ISO13485, FDA, EU MDR, cGMP, and other regulatory requirements.

The responsibilities of this position include:

  • Supporting QA strategy development, product registration, renewals, and regulatory submissions across global markets.
  • Coordinating with market representatives to stay updated on regulatory changes and integrate them into the QMS.
  • Providing support for QMS functions including document control, audits, CAPA, complaints, training, and recalls.
  • Acting as an independent reviewer for validation protocols and ensuring technical documentation is maintained and submission-ready.
  • Liaising with regulatory bodies, customers, and auditors, and assisting with inspection readiness and post-market surveillance.
  • Communicating regulatory changes and supporting their implementation across teams.

Requirements:

  • Minimum Diploma in Life Science or related field.
  • Entry level candidates are welcome to apply, with training provided.
  • Knowledge or experience with ISO 13485 is an added advantage.

Key Qualifications:

  • Quality Assurance Management.
  • Technical Documentation.
  • CAPA.
  • FDA.
  • Regulatory Affairs.
  • Inventory.
  • ISO.
  • Audits.


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