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Medical Device Regulatory Affairs Specialist

2 months ago

Shanghai, Shanghai, China Siemens Healthineers Ltd. Full time
Key Responsibilities

As 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:
  1. 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.
  2. Closely collaborate with external and internal partners to establish and adapt registration strategies according to emerging and evolving regulations.
  3. Collaborate with regulatory partners, including both domestic and foreign manufacturers, to achieve product licenses.
  4. Ensure the regulatory alignment between domestic and foreign product license holders.
  5. Maintain or develop good working relationships and cooperation with relevant authorities such as test labs, CMDE, NMPA, etc. to improve working efficiency.
  6. Work closely with China Marketing, US colleagues, et al. on all regulatory issues, including communication with R&D on NMPA registration document requirements.
  7. Support and coordinate activities in product inspections by local authorities and coordinate activities in product standard development or revision.
  8. Monitor and support market research on relevant government and competitive activities.
Requirements

To be successful in this role, you will require:

Requirements:
  1. A minimum of 5 years working experience in medical device product registration, particularly for diagnostic ultrasound systems and accessories.
  2. Established regulatory experience and knowledge in the medical device industry; experience in obtaining product registration licenses with multiple models.
  3. Expertise in product-specific regulatory and standard requirements for China registration.
  4. Demonstrable effective cross-functional and intercultural working experience in a global company.
  5. Bachelor degree or above in a relevant field such as medical, biological, or engineering.
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.

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 care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously.