About the CompanyOur 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 TeamYou will be working in a team of 3 and reporting to the Regional Head of Quality and Regulatory. About the jobAs a Regional Regulatory Affairs Manager, you willobtain 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 countrieswork cross-functionally in order to provide regulatory input for product development and improvementsupports audit internally and externally draft and review regulatory documentsmaintain and develop SOPs on RA and product safety maintain good relationship with internal and external parties such as distributors, commercial teams and service teamsSkills & Experience requiredbachelor’s Degree in Biomedical engineering or science related aspects at least 4 years of experience as regulatory affairs in Medical device/ Pharmaceuticals sectorexperienced 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 consideredInterested parties, please apply directly with your current and expected salary. Feel free to reach out to Perry Chung at firstname.lastname@example.org for any questions you might have.