Senior Regulatory Affairs Specialist

6 days ago

Shanghai, Shanghai, China Siemens Healthineers Ltd. Full time
About the Role

We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team at Siemens Healthineers Ltd. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices in China and other markets.

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.
  • Closely communicate 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 relationship and cooperation with relevant authorities such as test labs, CMDE, NMPA etc. to improve working efficiency.
  • Work closely with China Marketing, US colleagues, et al. 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 company's initiative and growth.
Requirements
  • Minimum of 5 years working experiences in medical device product registration, particularly for the 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 degree or above relevant in medical/ biological/engineering etc.

  • Regulatory Affairs Specialist

    3 weeks ago

    Shanghai, Shanghai, China Siemens Healthineers Ltd. Full time

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Siemens Healthineers Ltd. as a Senior Regulatory Affairs Specialist.Key ResponsibilitiesChampion the definition, alignment, and adoption of product design characteristics, practices, and outcomes with cross-functional stakeholders to enable the most...

  • Senior Regulatory Affairs Specialist

    2 days ago

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

    About the RoleWe are seeking a highly skilled Senior Regulatory Affairs Officer to join our team at Siemens Shanghai Medical Equipment Ltd. in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.Your Key ResponsibilitiesAs a Senior Regulatory Affairs Officer, you will be responsible for ensuring our products and processes comply...

  • Regulatory Affairs Specialist

    2 weeks ago

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

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Siemens Shanghai Medical Equipment Ltd. As a key member of our regulatory team, you will be responsible for ensuring our products and processes comply with relevant international and national standards and regulations.Key ResponsibilitiesEnsure product and process...

  • Regulatory Affairs Specialist

    2 weeks ago

    Shanghai, Shanghai, China Siemens Healthineers Ltd. Full time

    About the RoleWe 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 play a critical role in ensuring the compliance of our medical devices with regulatory requirements in China and other markets.Key ResponsibilitiesChampion the definition, alignment, and...

  • Regulatory Affairs Specialist

    4 weeks ago

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

    About Siemens Shanghai Medical Equipment Ltd.We are a leading medical technology company that pioneers breakthroughs in healthcare. Our mission is to create better outcomes and experiences for patients, regardless of their location or health issues.Your Role:As a Regulatory Affairs Specialist, you will be responsible for ensuring our medical products and...

  • Regulatory Affairs Specialist

    3 weeks ago

    Shanghai, Shanghai, China PSI Full time

    {"Job Title: Regulatory OfficerJob Summary:We are seeking a highly skilled Regulatory Officer to join our team at PSI. As a key member of our regulatory affairs team, you will be responsible for facilitating the start of research projects of novel medicinal products and taking a step further in your professional career.Key Responsibilities:* Monitor new...

  • Senior Regulatory Affairs Manager – Toxicologist

    2 days ago

    Shanghai, Shanghai, China Unilever Full time

    Main ResponsibilitiesAs a Senior Regulatory Affairs Manager – Toxicologist, you will play a crucial role in ensuring the successful landing of safety assessments for Unilever products in China markets.Key AccountabilitiesClosely collaborate with internal colleagues and external stakeholders to ensure the successful registration and notification of Unilever...

  • Regulatory Affairs Specialist

    4 days ago

    Shanghai, Shanghai, China PSI Full time

    Job Title: Regulatory OfficerJob Summary:We are seeking a highly skilled Regulatory Officer to join our team at PSI. As a Regulatory Officer, you will play a critical role in facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career.Key Responsibilities:Regulatory Intelligence:Monitor new...

  • Medical Affairs Specialist

    2 days ago

    Shanghai, Shanghai, China Medtronic Full time

    Transforming Healthcare with MedtronicAbout the RoleAs a Senior Medical Affairs Specialist at Medtronic, you will play a critical role in driving the development and implementation of evidence-based medical affairs strategies. Your expertise will be instrumental in providing medical input to various functions and organizational units, facilitating insightful...

  • Government Affairs Specialist

    2 days ago

    Shanghai, Shanghai, China MAHLE Full time

    Job SummaryWe are seeking a highly skilled Government Affairs Manager to join our team at MAHLE. The successful candidate will be responsible for developing and maintaining strong relationships with local government organizations in China, providing political and regulatory analysis, and ensuring regulatory compliance.Key ResponsibilitiesDevelop and maintain...

  • Senior Manager, Global Regulatory Compliance

    4 weeks ago

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

    Position Overview Hydrafacial Trading (Shanghai) Co Ltd is seeking a Senior Manager for International Regulatory Affairs. This role is pivotal in facilitating the entry of our innovative products into diverse markets while leading the charge on global regulatory submissions for medical devices and cosmetics. The successful candidate will act as the...

  • Senior Manager of Regulatory Affairs, Fintech

    4 weeks ago

    Shanghai, Shanghai, China HSBC Full time

    Join a Global Compliance Team Compliance serves as a pivotal function that integrates all dimensions of regulatory and financial crime risk management. As stewards of risk, we collaborate with various specialized teams to assist HSBC in navigating a multifaceted regulatory environment, ensuring a sustainable compliance risk management approach that promotes...

  • Head of Medical Scientific Affairs Director

    4 days ago

    Shanghai, Shanghai, China Roche Full time

    Job Title: Head of Medical Scientific AffairsRoche is seeking a highly skilled and experienced professional to lead our Medical Scientific Affairs function. As Head of Medical Scientific Affairs, you will be responsible for ensuring the management of the affiliate adheres to the highest scientific and ethical standards and fulfills all regulatory...

  • Lead Manager, International Regulatory Strategy

    4 weeks ago

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

    Position Overview Hydrafacial Trading (Shanghai) Co Ltd is seeking a Senior Manager for International Regulatory Affairs, a pivotal role in facilitating the entry of our innovative products into diverse global markets while leading the charge on regulatory submissions for medical devices and cosmetics. This position will serve as the primary authority...

  • Medical Affairs Specialist

    2 weeks ago

    Shanghai, Shanghai, China Medtronic Full time

    Transforming Healthcare with MedtronicAbout the RoleAs a Medical Affairs Specialist at Medtronic, you will play a critical role in driving the development and implementation of evidence-based medical affairs strategies for our organization. Your expertise will be essential in providing medical input to various functions and organizational units, facilitating...

  • Regulatory Compliance Manager

    4 weeks ago

    Shanghai, Shanghai, China Advanced Sterilization Products Full time

    About the RoleAs a Quality Assurance Specialist at Advanced Sterilization Products, you will play a critical role in ensuring the quality and compliance of our sterilization processes and products. This position requires a strong understanding of regulatory requirements and industry standards, as well as excellent communication and analytical skills.Key...

  • Head of Medical Scientific Affairs

    6 days ago

    Shanghai, Shanghai, China Roche Full time

    Job SummaryAs a key member of the Roche team, the Head of Medical Scientific Affairs will be responsible for leading the medical scientific affairs function, ensuring its management of the affiliate adheres to the highest scientific and ethical standards and fulfills all regulatory requirements. This position provides strategic directions and contributes to...

  • Government Affairs Specialist

    2 weeks ago

    Shanghai, Shanghai, China Dupont Full time

    About DuPontDuPont is a premier multi-industrial company delivering sustainable solutions that bring real purpose and value. We believe in the power of collaboration and diversity of thought, and we're committed to empowering the world with essential innovations to thrive.Job SummaryWe're seeking a Government Affairs Manager to join our Shanghai office. As a...

  • Government Affairs Specialist

    3 weeks ago

    Shanghai, Shanghai, China Dupont Full time

    {"title": "Government Affairs Manager", "description": "Empowering InnovationAt DuPont, we are committed to delivering sustainable solutions that bring real purpose and value. We believe that our employees are the key to our success, and we are seeking a talented Government Affairs Manager to join our team in Shanghai.Key ResponsibilitiesAdvise corporate and...

  • Senior Regulatory Affairs Manager – Toxicologist/高级法规经理-毒理

    4 weeks ago

    Shanghai, Shanghai, China Unilever Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist – Toxicology Expert to join our team at Unilever. As a key member of our Safety and Environmental Assurance Centre (SEAC), you will play a critical role in ensuring the successful landing of safety assessments for our products in China markets.Main ResponsibilitiesCollaboration and...