Medical Device Compliance Specialist
6 days ago
We are seeking an experienced Regulatory Affairs Specialist to oversee medical device registrations, ensure compliance with regulations, and provide guidance on regulatory strategies. The ideal candidate will have experience working at the Health Sciences Authority (HSA) or prior experience in medical device regulatory affairs.
Key Responsibilities- Prepare, review, and submit medical device registration dossiers to HSA. Monitor submissions in other ASEAN countries handled by local regulatory personnel.
- Advise on regulatory strategy, product classification, labeling, and compliance requirements.
- Monitor regulatory changes and provide guidance to ensure ongoing compliance in Singapore and ASEAN markets.
- Support post-market surveillance activities.
- Point of contact for manufacturers' regulatory teams and regulatory authorities, ensuring smooth and timely registration processes.
- Minimum 2–5 years of regulatory affairs experience, either from prior work in HSA or a regulatory affairs role in medical devices.
- Strong knowledge of Singapore medical device regulations (HSA); familiarity with other ASEAN regulations is an advantage.
- Ability in speaking Chinese is a requirement.
- Strong organizational and project management skills; able to handle multiple submissions simultaneously.
- Familiarity with Therapeutic Products License (TPL) is preferred.
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