Healthcare Regulatory Affairs Professional

3 days ago

Singapore beBeeRegulatory Full time $5,000 - $5,500
Regulatory Affairs Expert

This role plays a vital part in ensuring the seamless execution of regulatory affairs for healthcare businesses across Singapore and Malaysia.

Key Responsibilities Include:

  • Data Management: Coordinate, update, and maintain regulatory data tracking tools and project databases for product submissions, approval, renewals, and variations.
  • Process Monitoring: Track and follow up on project processes and deliverables across global and SEA teams.
  • Collaboration: Consolidate and provide updates to SEA team for rebranding project review meetings, highlighting key trends, risks, and delays.
  • Support Activities: Assist with assigned rebranding activities for SEA team.
  • Clinical Clearance: Support pre-market regulatory clearances and post-market regulatory activities.
  • Registration Requirements: Familiarize with registration requirements.
  • Dossier Assessment: Collect and assess registration dossier and address the gap of technical deficiencies.
  • Submission: Submit registration dossier and follow through all in-process evaluation until regulatory clearance is obtained.
  • Data Integrity: Manage regulatory systems and tools to drive operational excellence for effective data tracking and ensure regulatory data integrity.
  • FSCA Compliance: Execute all warranted FSCA and follow-up all through until closure, including preparation and submission of relevant FSCA reports to regulatory authorities.
  • Adverse Event Reporting: Assist with adverse event reporting and follow-up through until closure to ensure regulatory compliance.

Required Skills and Qualifications:

  • Education: Bachelor of Science or Biomedical Science related degree.
  • Experience: Relevant experiences in healthcare industry required.
  • Skills: Around 2 years of regulatory working experiences, preferably in medical device industry. Knowledge of ASEAN medical devices regulatory requirements. Self-learner and comfortable with continuous learning in regulatory and technology subjects.

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