about the company. ...
international regulatory affairs manager.
- hong kong
- posted 1 day ago
- closes 30 june 2025
job details
summary
- hong kong
- HK$55,000 - HK$65,000 per year
- permanent
- full-time
- specialismlife sciences
- sub specialismregulatory affairs
- reference number91M0249317_0989716146036498305
job details
Our client is an emerging medical devices company seeking for a Regulatory Affairs Manager to drive product registeration outside of Hong Kongabout the job.
skills & experiences required.
show more- Prepare and compile comprehensive regulatory submissions focused on the European Union Medical Device Regulation and Asia-Pacific markets.
- Manage the lifecycle of regulatory submissions, including addressing ongoing inquiries and requests for additional information from regulatory authorities and Notified Bodies.
- Conduct thorough regulatory and scientific research to support submission requirements and address emerging issues.
- Contribute to the development of regulatory strategies by identifying product classifications and assisting in the formulation of effective pathways to market.
- Support the creation of robust submission documentation through literature reviews and the synthesis of relevant scientific and regulatory information.
- Ensure regulatory compliance by identifying and interpreting applicable standards and guidance documents, and participating in meetings with regulatory agencies under the direction of leadership.
skills & experiences required.
- Degree in Science or a related major
- 5 years of relevant regulatory affairs experience in the medical device industry
- Knowledge of medical device regulations and/or biologics regulations, i.e., US FDA 21 CFR, European regulations (i.e., MDD/MDR), Health Canada, 21 CFR 820, ISO 13485, MDSAP, other global regulations and standards as relates to submissions to governmental and other agencies, as well as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
about the company.
Our client is an emerging medical devices company seeking for a Regulatory Affairs Manager to drive product registeration outside of Hong Kong
- Prepare and compile comprehensive regulatory submissions focused on the European Union Medical Device Regulation and Asia-Pacific markets.
- Manage the lifecycle of regulatory submissions, including addressing ongoing inquiries and requests for additional information from regulatory authorities and Notified Bodies.
- Conduct thorough regulatory and scientific research to support submission requirements and address emerging issues.
- Contribute to the development of regulatory strategies by identifying product classifications and assisting in the formulation of effective pathways to market.
- Support the creation of robust submission documentation through literature reviews and the synthesis of relevant scientific and regulatory information.
- Ensure regulatory compliance by identifying and interpreting applicable standards and guidance documents, and participating in meetings with regulatory agencies under the direction of leadership.
...
skills & experiences required.
show more- Degree in Science or a related major
- 5 years of relevant regulatory affairs experience in the medical device industry
- Knowledge of medical device regulations and/or biologics regulations, i.e., US FDA 21 CFR, European regulations (i.e., MDD/MDR), Health Canada, 21 CFR 820, ISO 13485, MDSAP, other global regulations and standards as relates to submissions to governmental and other agencies, as well as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)
skills
no additional skills requiredqualifications
no additional qualifications requirededucation
Bachelor Degree
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