Regulatory Affairs Expert for Medical Devices

4 days ago

Shanghai, Shanghai, China Siemens Healthineers Ltd. Full time

Are you passionate about regulatory affairs and the medical device industry?

About the Role

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Siemens Healthineers Ltd.

Key Responsibilities
  • Champion product design characteristics, practices, and outcomes with cross-functional stakeholders to enable business-relevant and fastest-to-market registration strategies.
  • Closely collaborate with external and internal partners to establish and adapt registration strategies according to emerging and evolving regulations.
  • Work closely with China Marketing, US colleagues, et al. on all regulatory issues, including communication with R&D on NMPA registration document requirements.
  • Maintain or develop good working relationships and cooperation with relevant authorities such as test labs, CMDE, NMPA etc. to improve working efficiency.
  • Support and coordinate activities in product inspections by local authorities and coordinate activities in product standard development or revision.
  • Monitor and support market research on relevant government and competitive activities.
Requirements
  • Minimum 5 years of working experience in medical device product registration, particularly for diagnostic ultrasound systems and accessories.
  • Established regulatory experiences and knowledge in medical device industry; experience in obtaining product registration licenses with multiple models.
  • Expertise in product-specific regulatory and standard requirements for China registration.
  • Demonstrable effective cross-functional and intercultural working experiences in a global company.
  • Bachelor's degree or above in a relevant field (medical, biological, engineering, etc.).
About Us

We are a global team of over 66,000 dedicated employees across more than 70 countries. We push the boundaries of what's possible in healthcare to help improve people's lives worldwide.

Our culture is built on inclusivity, where every individual can unleash their power and potential. We spark ideas that lead to positive impact and continued success.

As an equal opportunity employer, we welcome applications from individuals with disabilities. We take compliance with GDPR and other data protection legislation seriously.

We estimate the salary for this role to be around $120,000 per annum, depending on location and experience.

  • Regulatory Affairs Specialist for Medical Devices

    1 week ago

    Shanghai, Shanghai, China Siemens Shanghai Medical Equipment Ltd. Full time

    We are a team of experts in regulatory affairs at Siemens Shanghai Medical Equipment Ltd., dedicated to ensuring our medical devices comply with international and national standards.As a Regulatory Affairs Specialist, you will play a crucial role in ensuring our products meet the necessary regulatory requirements. Your responsibilities will include:Key...

  • Medical Devices Regulatory Expert

    3 weeks ago

    Shanghai, Shanghai, China Siemens Shanghai Medical Equipment Ltd. Full time

    Your Role:As a Senior Regulatory Affairs Officer for Siemens Shanghai Medical Equipment Ltd., you will ensure our medical products and processes comply with international and national standards and regulations. This includes taking responsibility for product registration, ensuring compliance with relevant laws and regulations, and coordinating market...

  • Medical Device Regulatory Affairs Specialist

    3 weeks ago

    Shanghai, Shanghai, China Siemens Healthineers Ltd. Full time

    Key ResponsibilitiesAs a Senior Regulatory Affairs Specialist at Siemens Healthineers Ltd., you will champion the definition, alignment, and adoption of product design characteristics, practices, and outcomes with cross-functional stakeholders to enable the most business relevant and fastest to market registration strategies.Key Responsibilities:Champion the...

  • Regulatory Affairs Manager

    1 month ago

    Shanghai, Shanghai, China Hydrafacial Trading (Shanghai) Co Ltd (China) Full time

    Job SummaryHydrafacial Trading (Shanghai) Co Ltd (China) is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key contributor, you will play a crucial role in bringing our products into new markets and spearheading global medical device/cosmetic regulatory submissions.Key ResponsibilitiesLead all regulatory affairs transactions...

  • Senior Regulatory Affairs Specialist

    1 month ago

    Shanghai, Shanghai, China Siemens Shanghai Medical Equipment Ltd. Full time

    As a Senior Regulatory Affairs Specialist at Siemens Shanghai Medical Equipment Ltd., you will play a crucial role in ensuring our medical devices comply with international and national standards and regulations. Your expertise will be essential in product registration and maintaining market clearance.Key responsibilities include:Ensuring product and process...

  • Regulatory Affairs Specialist, International Markets

    4 weeks ago

    Shanghai, Shanghai, China Hydrafacial Trading (Shanghai) Co Ltd (China) Full time

    About the Role:Hydrafacial Trading (Shanghai) Co Ltd (China) is seeking a highly skilled Regulatory Affairs Specialist to join their team. As a key contributor, you will play a vital role in bringing the company's products into new markets and spearheading global medical device/cosmetic regulatory submissions.Key Responsibilities:Lead all regulatory affairs...

  • Regulatory Affairs Expert

    1 month ago

    Shanghai, Shanghai, China Siemens Healthineers Ltd. Full time

    About the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Siemens Healthineers Ltd. As a key member of our regulatory team, you will be responsible for championing the definition, alignment, and adoption of product design characteristics, practices, and outcomes with cross-functional stakeholders to enable the most...

  • Regulatory Affairs Strategist for International Market Expansion

    1 week ago

    Shanghai, Shanghai, China Hydrafacial Trading (Shanghai) Co Ltd (China) Full time

    Job DescriptionAbout UsHydrafacial Trading (Shanghai) Co Ltd is a leading player in the global beauty industry, dedicated to providing innovative skincare solutions.SalaryThe estimated annual salary for this role is $120,000 - $180,000, depending on experience.Job OverviewWe are seeking an experienced Regulatory Affairs Strategist to join our team and lead...

  • Regulatory Affairs Manager Shanghai

    6 days ago

    Shanghai, Shanghai, China CN20 Alcon (China) Ophthalmic Product Co. Ltd Company Full time

    CN20 Alcon (China) Ophthalmic Product Co. Ltd Company seeks a skilled Regulatory Affairs Manager to oversee government affairs and market access in Shanghai and Jiangxi provinces.About the RoleAs a Regulatory Affairs Manager, you will be responsible for:Familiarizing yourself with Shanghai/Jiangxi government affairs and market access procedures,...

  • Regulatory Affairs Manager

    1 month ago

    Shanghai, Shanghai, China Hydrafacial Trading (Shanghai) Co Ltd (China) Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Hydrafacial Trading (Shanghai) Co Ltd (China). As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements in APAC and China.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure compliance...

  • Senior Regulatory Affairs Manager

    3 weeks ago

    Shanghai, Shanghai, China Unilever Full time

    Main ResponsibilitiesCollaborate with internal stakeholders and external partners to ensure the safe assessment and registration of Unilever's products in the Chinese market.Provide expertise to address safety-related inquiries and challenges during product registration or post-market surveillance.Support the Science and Environment Assurance Centre (SEAC)...

  • Regulatory Affairs Expert

    3 weeks ago

    Shanghai, Shanghai, China International Flavors & Fragrances Full time

    Job SummaryWe are seeking a highly motivated and results-driven Regulatory Affairs Expert to join our Asia team in China. As a key member of our regulatory team, you will play a critical role in ensuring compliance with regulatory requirements for our flavor and fragrance products.Your Key ResponsibilitiesRegistration and ComplianceSupport the registration...

  • Global Regulatory Affairs Professional

    1 week ago

    Shanghai, Shanghai, China 3M Full time

    Regulatory Affairs SpecialistAt 3M, we empower employees to explore, innovate, and push boundaries.We are committed to innovation and provide the freedom to explore and encourage curiosity and creativity. As a result, you can apply your talent in bold ways that matter.The Impact You'll Make in this RoleThis role offers the opportunity to tap into your...

  • Regulatory Affairs Manager

    1 month ago

    Shanghai, Shanghai, China Nu Skin Full time

    About the Role:Nu Skin is seeking a highly skilled Regulatory Affairs Manager to oversee regulatory projects for our China operations. As a key member of our Regulatory Affairs Department, you will play a critical role in ensuring compliance with various regulations related to food and food supplements, electronic devices, and cosmetics.Key...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Shanghai, Shanghai, China Nu Skin Full time

    About the Role:Nu Skin is seeking a highly skilled Regulatory Affairs professional to oversee regulatory projects for China. As a member of our growing Regulatory Affairs Department, you will play a key role in ensuring compliance with various regulations related to food and food supplements, electronic devices, and cosmetics.Key Responsibilities:Lead...

  • Regulatory Affairs Specialist

    1 month ago

    Shanghai, Shanghai, China 3M Full time

    Job Title: Regulatory Affairs Specialist - China Market AccessThe Impact You'll Make in this RoleAs a Regulatory Affairs Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Primary Responsibilities include but are not limited to the following:Provide...

  • Global Medical Affairs Manager

    3 weeks ago

    Shanghai, Shanghai, China Roche Full time

    OverviewJob SummaryIn this key role, you will be responsible for the medical leadership of the assigned disease areas and related biomarkers in the region, working under the direction of the Associate Medical Director. As Country Medical Manager, you will provide critical medical input to support the deliverables of the medical plan/biomarker plan for...

  • Regulatory Affairs Specialist

    1 month ago

    Shanghai, Shanghai, China International Flavors & Fragrances Full time

    Job SummaryWe are seeking a highly motivated and results-driven individual to join our Asia team as Manager, Regulatory Affairs in China. This role reports to the Head of Greater China Regulatory Affairs and will preferably be located in Shanghai, China.Your Key ResponsibilitiesRegistration and compliance of IFF Nourish flavors used in food and...

  • Medical Affairs Specialist

    1 month ago

    Shanghai, Shanghai, China Roche Full time

    Job Title: Medical Affairs ExpertAbout the Role:We are seeking a highly skilled Medical Affairs Expert to join our team at Roche. As a Medical Affairs Expert, you will play a critical role in developing and implementing medical strategies to support our business objectives.Main Responsibilities:1. Collaborate with our Business Affairs team to develop and...

  • Senior Regulatory Affairs Lead

    4 weeks ago

    Shanghai, Shanghai, China Abbott Full time

    Job Description:Regulatory Affairs Manager for Pharmaceutical IndustryWelcome to the Abbott team as a Regulatory Affairs Manager for Pharmaceutical Industry! We are looking for a highly skilled and experienced professional to join our team.About the Role:Develop and implement regulatory strategies to ensure timely product approvals and compliance with CFDA...