Regulatory Affairs Specialist
3 days ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Siemens Healthineers Ltd. as a Senior Regulatory Affairs Specialist.
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 collaborate with external and internal partners to establish and adapt registration strategies according to emerging and evolving regulations.
- Work closely 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.
- 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.
- 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 a relevant field such as medical, biological, or engineering.
We are a global 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 spark ideas that lead to positive impact and continued success.
-
Regulatory Affairs Specialist
4 days ago
Shanghai, Shanghai, China Siemens Shanghai Medical Equipment Ltd. Full timeAbout 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
7 hours 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...
-
Regulatory Compliance Manager
6 days ago
Shanghai, Shanghai, China Advanced Sterilization Products Full timeAbout 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...
-
Shanghai, Shanghai, China Unilever Full timeJob 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...
-
Shanghai, Shanghai, China Roche Full timeJob Summary:The PositionJob Summary:Lead the medical scientific affairs function, ensuring its management of the affiliate adheres to the highest scientific and ethical standards and fulfills all regulatory requirements.Provide strategic directions and contribute to the collective medical management of the company and to the appropriate use of company...
-
Senior Manager, Global Regulatory Compliance
6 days ago
Shanghai, Shanghai, China Hydrafacial Trading (Shanghai) Co Ltd (China) Full timePosition 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...
-
Shanghai, Shanghai, China Hydrafacial Trading (Shanghai) Co Ltd (China) Full timePosition 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...
-
Regulatory Affairs Counsel
6 days ago
Shanghai, Shanghai, China Ingredion Trading (Shanghai) Limited Full timeLOCATION: Songjiang Province , Shanghai, China REPORTS TO: General Counsel, APAC & dotted line to Global Compliance Officer WORKPLACE TYPE: On-site Company Overview: Ingredion is a leading global provider of ingredient solutions, impacting millions of lives daily. With a diverse customer base exceeding 19,000 across 120 countries, we develop...
-
Quality Assurance Specialist
6 days ago
Shanghai, Shanghai, China Advanced Sterilization Products Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Advanced Sterilization Products. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and regulatory compliance in our operations.Key ResponsibilitiesImplement and maintain our Quality Management System,...
-
Legal and Regulatory Affairs Counsel
6 days ago
Shanghai, Shanghai, China Ingredion Trading (Shanghai) Limited Full timeLOCATION: Songjiang Province , Shanghai, China REPORTS TO: General Counsel, APAC & dotted line to Global Compliance Officer WORKPLACE TYPE: On-site Company Overview: Ingredion is a leading global provider of ingredient solutions that enhance the quality of life for millions of people daily. With a diverse customer base exceeding 19,000 across...
-
Shanghai, Shanghai, China Thermo Fisher Scientific Full timePosition OverviewAs a Trade Compliance Operation Specialist, you will play a crucial role in ensuring adherence to regulatory standards and facilitating smooth import/export processes. Your expertise will be vital in navigating complex compliance landscapes.Key ResponsibilitiesProduct Launch Compliance: Engage in new product introductions to verify...
-
Shanghai, Shanghai, China HSBC Full timeJoin 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...
-
Shanghai, Shanghai, China Thermo Fisher Scientific Full timeJob OverviewAs a Trade Compliance Operation Specialist, you will play a crucial role in ensuring adherence to regulatory standards during product launches and throughout the import/export process.Key ResponsibilitiesRegulatory Compliance: Collaborate on new product introductions to verify compliance with applicable regulations. Your meticulous attention to...
-
Shanghai, Shanghai, China Thermo Fisher Scientific Full timeJob OverviewAs a Trade Compliance Operation Specialist at Thermo Fisher Scientific, you will play a crucial role in ensuring adherence to regulatory standards in our international trade operations. Your expertise will be essential in navigating complex compliance landscapes.Key ResponsibilitiesProduct Launch Compliance: Collaborate on new product...
-
Associate Director, Legal Affairs
4 days ago
Shanghai, Shanghai, China IQVIA Full time**Job Overview**As a key member of the IQVIA team, the Associate Director, Legal Affairs will provide expert legal advice and services to support the company's business objectives. This role will involve reviewing, drafting, and negotiating a broad range of commercial contracts, ensuring compliance with legal, regulatory, and organizational policies.**Key...
-
Head of Medical and Clinical Affairs
3 days ago
Shanghai, Shanghai, China Philips Full timeAbout the Role:This is a senior leadership position that will lead a team to deliver clinical and medical knowledge, experience, and expertise across the value chain with a focus on ensuring insights on trends, practices, and ethics are embedded in the relevant Idea to Market processes. The role will also utilize insights for commercial purposes such as...
-
Director, Local Government Affairs
2 months ago
Shanghai, Shanghai, China Organon Full timeJob DescriptionResponsibilities:Lead local government affairs team to implement Organon China's business strategy through multiple access initiatives and achieve access targets in a matrix environment.Take lead in key market access activities, e.g., VBP tendering and price negotiation, PVBP management, NRDL implementation, Retail reimbursement, etc.Build up...
-
Type Approval Project Manager
7 hours ago
Shanghai, Shanghai, China General Motors Full timeJob Description General Motors is seeking a highly skilled Type Approval Project Manager to join our team. As a key member of our regulatory affairs team, you will be responsible for ensuring compliance with export/global regulatory requirements and export market certification requirements. Your Skills & Abilities (Required Qualifications) Bachelor of...
-
Sterilization Quality Control Lead
6 days ago
Shanghai, Shanghai, China Advanced Sterilization Products Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Advanced Sterilization Products. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and regulatory compliance in our operations.Key ResponsibilitiesImplement and maintain our Quality Management System,...
-
Sterilization Quality Control Lead
6 days ago
Shanghai, Shanghai, China Advanced Sterilization Products Full timeAbout the RoleWe are seeking a highly skilled Quality Assurance Specialist to join our team at Advanced Sterilization Products. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and regulatory compliance in our operations.Key ResponsibilitiesImplement and maintain our Quality Management System,...
