Job Description
- New headcount
- Rapid growing medical company
About our Client
Our client is a world renowned imaging company with a long heritage in manufacturing topnotch medical imaging technologies for the healthcare industry. To cope with their global business expansion plan, they would like to invite a Regulatory Affairs Specialist to join their regional team.
About the Role
Reporting to the Business Manager, you are responsible for regulatory affairs activities to assist in regulatory submission, registrations and listings on medical equipment for Hong Kong. You will develop and execute regulatory strategies for new and established products by working closely with the global headquarters' regulatory affairs division. You will assure compliance with applicable medical equipment regulations per jurisdiction guidance and standards for local registrations. Additionally, you will keep abreast on the latest regulatory rules in Europe, United States and other Asian countries.
Requirements
- Bachelor Degree holder in any Science related discipline
- Minimum 3 years' medical device regulatory relevant experience working at a sizable medical device company
- Strong product regulations, enforcement and industry practice relevant to the medical device industry
- Independent and a self-starter with the ability to make sound recommendations and decisions
- Must be able to work in a multi-cultural environment
- Strong technical knowledge in radio and electric power sources
- Proficient in spoken and written English and Chinese is a pre-requisite for this role
Click "Apply Now" to apply for this position or call Patsy Cheung at +852 3180 4917 for a confidential discussion. All information collected will be kept in strict confidence and will be used for recruitment purpose only.
