Regulatory Affairs Expert

2 weeks 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 business-relevant and fastest-to-market registration strategies.

Your Key Responsibilities:

  • Close communication with external and internal partners to establish and adapt registration strategies according to emerging and evolving regulations.
  • Collaborate with regulatory partners, including both domestic and foreign manufacturers, to achieve product licenses.
  • Ensure the regulatory alignment between domestic and foreign product license holders.
  • Maintain or develop good working relationships and cooperation with relevant authorities such as test labs, CMDE, NMPA, etc. to improve working efficiency.
  • Work closely with China Marketing, US colleagues, etc. on all regulatory issues, including communication with R&D on NMPA registration document requirements.
  • 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.
  • Define and support process changes to enhance regulatory efficiencies, productivity, and quality that are consistent with the company's initiative and growth.

Your Qualifications and Experience:

  • Minimum of 5 years of working experience in medical device product registration, particularly for diagnostic ultrasound systems and accessories.
  • Established regulatory experiences and knowledge in the 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 medical, biological, engineering, or a related field.

About Us:

We are a team of 66,000 highly dedicated employees across more than 70 countries, passionately pushing the boundaries of what's possible in healthcare to help improve people's lives around the world. We aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

Our Culture:

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible, to improve people's lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

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