
Medical Device Regulatory Expert
3 days ago
Our company is a leading provider of regulatory services for medical devices. We are seeking a skilled Regulatory Affairs Specialist to join our team.
About the RoleWe are looking for an experienced individual who can manage medical device registrations, ensure compliance with regulations, and provide guidance on regulatory strategy. The ideal candidate will have a strong knowledge of Singapore medical device regulations (HSA) and familiarity with other ASEAN regulations.
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.
To be successful in this role, you will need:
- A minimum of 2-5 years of experience in regulatory affairs, 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.
- Ability in speaking Chinese.
- Strong organizational and project management skills.
This is a challenging and rewarding role that offers:
- The opportunity to leverage your experience to lead submissions across multiple medical device product lines.
- The chance to work closely with clients and regulatory authorities in a high-impact role.
- Exposure to ASEAN regulatory environments while building professional expertise.
We are a specialist regulatory company offering career growth and professional development opportunities.
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