Regulatory Affairs Specialist, Apac

3 days ago

Singapore Revvity Full time

**Position overview**

Performs the coordination and preparation of document packages for regulatory submissions for new and mature products in APAC region (excluding Mainland China) to ensure alignment and compliance with local and regional registration requirements

**Major responsibility**

Regulatory Compliance:

- Stay updated with evolving regulatory changes and communicate their impact on product development and approval processes within the APAC region.
- Prepare and submit regulatory submissions, including product registrations, variations, and renewals, to regulatory authorities in APAC countries.
- Collaborate with internal teams to gather necessary technical documentation and data for regulatory submissions in accordance with APAC regulatory requirements.

Regulatory Strategy for APAC Markets:

- Develop and implement regulatory strategies to support the successful approval and commercialization of medical devices within APAC markets.
- Provide regulatory guidance to cross-functional 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.
- Participate in regulatory meetings with authorities to address queries, provide clarifications, and support regulatory approvals within the APAC region.

Regulatory Compliance Audits and Inspections:

- Assure continuous compliance with Health Surveillance Agency’s regulation
- Support internal and external audits and inspections related to regulatory compliance within APAC markets.
- Support global recalls and field action in the APAC region, including for countries not regulated

Regulatory Intelligence and Training:

- Monitor changes in regulatory requirements, standards, and guidance documents specific to APAC markets.
- Conduct training sessions and provide guidance to internal stakeholders on APAC regulatory requirements and updates.
- Collaborate with regional regulatory affairs organizations and industry associations within APAC to stay informed about regional best practices and regulatory trends.

**Education**

Bachelor’s degree in related field (such as science, chemistry, medical or engineering discipline)
Fluent English

**Experience/Skills**
- 5+ years experience in medical device RA/QA, IVD work experience is preferred
- Experience in preparing and submitting regulatory filings and registrations for IVD medical devices in SEA region is preferred
- Familiarity with regional regulatory requirements, including registration processes, technical documentation, and labeling guidelines.
- Excellent analytical, problem-solving, and organizational skills.
- Strong attention to detail and ability to work independently and collaboratively.

**Travel Availability**
10%

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