Senior Regulatory Affairs Specialist

2 weeks ago

Shanghai, Shanghai, China Siemens Healthineers Ltd. Full time
Do you want to join us in helping to fight diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere. We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally.

Your tasks and 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.Close communication 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 relationship 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.

9.Defines and support process changes to enhance regulatory efficiencies, productivity, and quality that are consistent with company's initiative and growth.

Your qualifications and experience:

1.Minimum of 5 years working experiences in medical device product registration, particularly for the diagnostic ultrasound systems and accessories.

2.Established regulatory experiences and knowledge in 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 experiences in a global company.

Bachelor degree or above relevant in medical/ biological/engineering etc.

Our global team:

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.As an equal opportunity employer, we welcome applications from individuals with disabilities.We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.

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