Regulatory Affairs Specialist

2 weeks ago


Singapore BRUNEL INTERNATIONAL SOUTH EAST ASIA PTE. LTD. Full time
Our client is a MNC in the Medical Devices industry with a strong and expanding portfolio

Roles and Responsibilities

  • Prepare and submit regulatory submissions, including product registrations, variations, and renewals, to regulatory authorities in APAC countries.
  • Develop and implement regulatory strategies to support the successful approval and commercialization of medical devices within APAC markets.
  • Provide regulatory guidance to crossfunctional teams on regional regulatory requirements and strategies for new product development.
  • Conduct regulatory assessments for product changes, labeling updates, and manufacturing process modifications specific to APAC markets.
  • Support internal and external audits and inspections related to regulatory compliance
  • Monitor changes in regulatory requirements, standards, and guidance documents specific to APAC markets.

Why you should apply
This is an exciting opportunity in a well established global company with a strong product portfolio. It's a great opportunity to gain more regional exposure in the RA space.

What you should do now
(Registration Number
:
R
| Consultant License Number A)

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