Regulatory Affairs Expert

6 hours ago


Singapore beBeeRegulatory Full time $120,000 - $200,000
Job Description

We are seeking a highly skilled Regulatory Affairs Manager to join our team. This role will ensure regulatory compliance and execute robust quality assurance practices in the Asia Pacific region.

Key Responsibilities
  • Develop and execute regional regulatory strategies for medical devices, ensuring compliance with country-specific laws and requirements.
  • Manage regulatory submissions and approvals across India and ASEAN markets.
  • Monitor evolving regulatory environments and proactively advise stakeholders on key changes and implications.
  • Train and guide internal teams on regional regulatory requirements and best practices.
  • Build and sustain relationships with local regulatory bodies, industry associations, and external partners.
  • Maintain and enhance Quality Management Systems and QA programs to align with global and regional standards.
Required Skills and Qualifications
  • Bachelor's degree in life sciences, engineering, or a related discipline (advanced degree preferred).
  • Minimum 8 years of experience in Regulatory Affairs or combined Regulatory and Quality roles, with direct market approval experience in India and/or ASEAN countries.
  • Deep understanding of regulatory frameworks, including CDSCO (India), AMDD (ASEAN), and international standards such as ISO 13485.
  • Proven success in managing regulatory submissions and securing approvals.
  • Hands-on experience with quality management systems (e.g., ISO 9001, ISO 13485).
  • Professional fluency in English.
Benefits

This role offers a unique opportunity to work in a dynamic environment and make a significant impact on the company's success. If you have a strong background in Regulatory Affairs and are looking for a new challenge, please apply.



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