Medical Device Compliance Expert
2 weeks ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. This individual will be responsible for managing medical device registrations, ensuring compliance with regulations, and providing guidance on regulatory strategy.
Key Responsibilities:
- Prepare, review, and submit medical device registration dossiers to the relevant authorities and monitor submissions in other regions 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 various markets.
- Support post-market surveillance activities.
- Serve as a point of contact for manufacturers' regulatory teams and regulatory authorities, ensuring smooth and timely registration processes.
Requirements:
- Minimum 2–5 years of regulatory affairs experience, either from prior work at a similar organization or a regulatory affairs role in medical devices.
- Strong knowledge of medical device regulations; familiarity with other regional regulations is an advantage.
- Ability in speaking both English and Chinese is a requirement.
- Strong organizational and project management skills; able to handle multiple submissions simultaneously.
- Familiarity with regulatory licenses is preferred.
Work Environment:
- Office-based role.
- Monday – Friday, 9:00 am – 6:00 pm.
- Location: Our headquarters.
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