Regulatory Affairs Specialist

21 hours ago

Shanghai, Shanghai, China Siemens Healthineers Ltd. Full time
Unlock Your Potential in Regulatory Affairs

Are you passionate about ensuring the safety and efficacy of medical devices? Do you have a keen eye for detail and a knack for navigating complex regulatory landscapes? We're seeking a highly skilled Regulatory Affairs Specialist to join our team at Siemens Healthineers Ltd.

Your Key Responsibilities:
  • 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.
  • Cultivate 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, to improve working efficiency.
  • Work closely with China Marketing, US colleagues, and others 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 experience 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 a relevant field, such as medical, biological, or engineering.

We're a global team of 66,000 dedicated employees across more than 70 countries, passionate about 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're facing. 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 care about your data privacy and take compliance with GDPR and other data protection legislation seriously. Please create a profile in our talent community to upload your CV and be alerted when relevant positions become open.

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