About the Company
Our client is a German medical company which focuses on both devices and drugs. They are now looking for a Regional Regulatory Affairs manager for the APAC market. They have over 30 production sites globally to provide products and services for patients with a specific disease. If you are looking for a regional exposure within the medical field, please apply!
About the Team
You will be working in a team of 3 and reporting to the Regional Head of Quality and Regulatory.
About the job
As a Regional Regulatory Affairs Manager, you will
- obtain product approvals in different APAC countries (e.g. Australia, Malaysia, Singapore, TW, etc.)
- apply for new product registrations in Germany and APAC countries and make sure it’s complied with local medical devices or drug’s regulations
- responsible to prepare regulatory materials for MDR, recall and adverse events
- responsible for medical devices and drug’s complaints regarding to the regulatory issues
- maintain and develop product licenses in APAC countries
- work cross-functionally in order to provide regulatory input for product development and improvement
- supports audit internally and externally
- draft and review regulatory documents
- maintain and develop SOPs on RA and product safety
- maintain good relationship with internal and external parties such as distributors, commercial teams and service teams
Skills & Experience required
- bachelor’s Degree in Biomedical engineering or science related aspects
- at least 4 years of experience as regulatory affairs in Medical device/ Pharmaceuticals sector
- experienced in handling medical devices/ drugs from europe or united state
- experienced in working across the APAC areas
- excellent command in oral and written English, Mandarin and Cantonese
- Candidates without concrete regional experience will also be considered
Interested parties, please apply directly with your current and expected salary. Feel free to reach out to Perry Chung at perry.chung@randstad.com.hk for any questions you might have.