Regulatory Affairs Expert

23 hours ago


Singapore beBeeQuality Full time $65,000 - $85,000
Job Description

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for developing and implementing regulatory strategies for new products, ensuring timely submission and approval of regulatory applications, and maintaining quality compliance with applicable standards.

The ideal candidate will have a strong understanding of regulatory requirements and procedures, excellent analytical and communication skills, and the ability to work effectively in a fast-paced environment.

Required Skills and Qualifications
  • Bachelor's degree in science or engineering
  • Knowledge of MD/IVDMD regulatory requirements, processes, and submission types (local/regional)
  • Knowledge of ISO 9001:2015, GDPMDS SS60 Quality Management System requirements
Key Responsibilities:
  1. Develop and implement regulatory strategies for new products
  2. Ensure timely submission and approval of regulatory applications
  3. Maintain quality compliance with applicable standards
  4. Perform quality analysis on shipments and manage internal & external audits
  5. Coordinate and monitor field actions implementation and complaint handling
  6. Manage and coordinate CAPA and vigilance activities
Seniority level:
  • Associate
Employment type:
  • Full-time
Job function:
  • Regulatory Affairs
Industries:
  • Biotechnology Research and Medical Equipment Manufacturing


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