SSME MI Senior Regulatory Affairs Officer
4 months ago
Joinus in pioneering breakthroughs in healthcare. For everyone. Everywhere.Sustainably.
Ourinspiring and caring environment forms a global community that celebratesdiversity and individuality. We encourage you to step beyond your comfort zone,offering resources and flexibility to foster your professional and personalgrowth, all while valuing your unique contributions.
Your role:
EnsureSSME products and process complying with relevant international and nationalstandards and regulations. Take responsibility for product registration.
•Ensure product and processcompliance with relevant and international laws and regulations.
•Catch regulations and standardsupdates, to ensure they could be implemented in related SOPs and products.
•Establish and maintain productmarket clearance and other compulsory certification process.
•Responsible for market clearance andother compulsory certificate for new product and transferred product.
•Communicate with government officeand Siemens internal relevant organization to set up a network to improvemarket clearance process.
•Cooperate and coordinate closelywith new project team to ensure market clearance and other compulsorycertificate process smoothly and efficiently.
•Well communicate with business uniteabout the progress and status.
•Responsible for coordination offactory inspection from third party.
•Coordinate cross RA workshop includeglobal RA workshop.
•Regulation knowledge sharing inteam.
•Other tasksassigned by supervisors, i.e. post market RA tasks, and etc.
Your expertise:
At least 5 years experience in Regulatory affairs.
•Be familiar with China andinternational regulations on medical devices in registration and development.
•Experience in R&D projectquality management or clinical evaluation is a plus.
•Goodrelationship with NMPA.
•Good experience for medical devices testing andtechnological requirement is preferred.
Who we are:
We are a team of more than 71,000 highly dedicated Healthineers in more than 70countries. As a leader in medical technology, we constantly push the boundariesto create better outcomes and experiences for patients, no matter where theylive or what health issues they are facing. Our portfolio is crucial forclinical decision-making and treatment pathways.
How we work:
When you join Siemens Healthineers, you become one in a global team ofscientists, clinicians, developers, researchers, professionals, and skilledspecialists, who believe in each individual’s potential to contribute withdiverse ideas. We are from different backgrounds, cultures, religions,political and/or sexual orientations, and work together, to fight the world’smost threatening diseases and enable access to care, united by one purpose: topioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.
Asan equal opportunity employer, we welcome applications from individuals withdisabilities.
Wecare about your data privacy and take compliance with GDPR as well as otherdata protection legislation seriously. For this reason, we ask you not to sendus your CV or resume by email. Please withinour talent community and subscribe to personalized job alert that will keep youposted about new opportunities.
-
SSME MI Test Engineer
4 months ago
Shanghai, China Siemens Shanghai Medical Equipment Ltd. Full timeJoinus in pioneering breakthroughs in healthcare. For everyone. Everywhere.Sustainably. Ourinspiring and caring environment forms a global community that celebratesdiversity and individuality. We encourage you to step beyond your comfort zone,offering resources and flexibility to foster your professional and personalgrowth, all while valuing your unique...
-
Senior Regulatory Affairs Specialist
1 month ago
Shanghai, Shanghai, China Nu Skin Full timeAbout the Role:Nu Skin is seeking a highly skilled Regulatory Affairs professional to oversee regulatory projects for China. As a member of our growing Regulatory Affairs Department, you will play a key role in ensuring compliance with various regulations related to food and food supplements, electronic devices, and cosmetics.Key Responsibilities:Lead...
-
Regulatory Affairs Specialist
2 months ago
Shanghai, China 3M Full time3M has a long-standing reputation as a company committed to innovation. We provide the freedom to explore and encourage curiosity and creativity. We gain new insight from diverse thinking, and take risks on new ideas. Here, you can apply your talent in bold ways that matter. Job Description: The Impact You’ll Make in this Role As a Regulatory Affairs...
-
Senior Regulatory Affairs Lead
1 month ago
Shanghai, Shanghai, China Abbott Full timeJob Description:Regulatory Affairs Manager for Pharmaceutical IndustryWelcome to the Abbott team as a Regulatory Affairs Manager for Pharmaceutical Industry! We are looking for a highly skilled and experienced professional to join our team.About the Role:Develop and implement regulatory strategies to ensure timely product approvals and compliance with CFDA...
-
Regulatory Affairs Director
4 weeks ago
Shanghai, Shanghai, China Abbott Full timeCompany Overview:We are a leading healthcare company, and we are seeking a highly skilled Regulatory Affairs Director to join our team.Job Description:The Regulatory Affairs Director will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulations and guidelines.The ideal candidate will have extensive...
-
Global Regulatory Affairs Professional
4 weeks ago
Shanghai, Shanghai, China 3M Full timeRegulatory Affairs SpecialistAt 3M, we empower employees to explore, innovate, and push boundaries.We are committed to innovation and provide the freedom to explore and encourage curiosity and creativity. As a result, you can apply your talent in bold ways that matter.The Impact You'll Make in this RoleThis role offers the opportunity to tap into your...
-
Regulatory Officer.
6 months ago
Shanghai, China PSI Full timeJob Description Join our team of experts in regulatory and ethics submissions of clinical studies. You will focus on facilitating the start of research projects of novel medicinal products, while taking a step further in your professional career. Office-based in Shanghai Office Your role: REGULATORY INTELLIGENCE Monitor new...
-
Manager, Regulatory Affairs
5 months ago
Shanghai, China International Flavors & Fragrances Full timeJob Description Summary Are you passionate about Regulatory Affairs? Would you love to work for a global organization that is “Doing More Good” for people and planet? Joining science and creativity, we are an international collective of thinkers who partner with customers to bring scents, tastes, experiences, ingredients, healthy and...
-
Shanghai, Shanghai, China Siemens Shanghai Medical Equipment Ltd. Full timeWe are a team of experts in regulatory affairs at Siemens Shanghai Medical Equipment Ltd., dedicated to ensuring our medical devices comply with international and national standards.As a Regulatory Affairs Specialist, you will play a crucial role in ensuring our products meet the necessary regulatory requirements. Your responsibilities will include:Key...
-
Senior Regulatory Affairs Manager
1 month ago
Shanghai, Shanghai, China Unilever Full timeMain ResponsibilitiesCollaborate with internal stakeholders and external partners to ensure the safe assessment and registration of Unilever's products in the Chinese market.Provide expertise to address safety-related inquiries and challenges during product registration or post-market surveillance.Support the Science and Environment Assurance Centre (SEAC)...
-
Regulatory Affairs Specialist
4 weeks ago
Shanghai, Shanghai, China PSI Full timeCompany OverviewPSI is a leading provider of regulatory and ethics submissions for clinical studies.Salary$120,000 - $180,000 per annum, depending on experience.Job DescriptionThis role involves facilitating the start of research projects for novel medicinal products while taking a step further in your professional career.Your Role:Regulatory...
-
Regulatory Affairs Manager Shanghai
4 weeks ago
Shanghai, Shanghai, China CN20 Alcon (China) Ophthalmic Product Co. Ltd Company Full timeCN20 Alcon (China) Ophthalmic Product Co. Ltd Company seeks a skilled Regulatory Affairs Manager to oversee government affairs and market access in Shanghai and Jiangxi provinces.About the RoleAs a Regulatory Affairs Manager, you will be responsible for:Familiarizing yourself with Shanghai/Jiangxi government affairs and market access procedures,...
-
Sr Manager, International Regulatory Affairs
7 months ago
Shanghai, China Hydrafacial Trading (Shanghai) Co Ltd (China) Full timeDescription : Hydrafacial is hiring a Sr. Manager, International Regulatory Affairs, who is a key contributor in bringing the company’s products into new markets and spearheading global medical device/cosmetic regulatory submissions. Serves as the internal subject matter expert for international regulatory affairs on assigned projects/regions,...
-
Senior Regulatory Affairs Manager
1 month ago
Shanghai, China Abbott Full timeEXPERIENCE: Over 5 years working experience in regulatory affairs for pharmaceuticals including more than 3 years in the project management post; Solid registration project management skills; Effective problem solving and planning capabilities; Good knowledge of CFDA regulations and guidelines; Good working relationship with regulatory authorities; ...
-
Senior Compliance Officer
4 weeks ago
Shanghai, Shanghai, China 10780 Citibank (China) Co., Ltd. Full timeJob DescriptionThe KYC Operations Manager is an essential role in ensuring the development and management of a dedicated internal KYC (Know Your Client) program at Citi.About the RoleThis position provides full leadership and direction to a team of employees, responsible for Anti-Money Laundering (AML) monitoring, governance, oversight, and regulatory...
-
Medical Devices Regulatory Expert
1 month ago
Shanghai, Shanghai, China Siemens Shanghai Medical Equipment Ltd. Full timeYour Role:As a Senior Regulatory Affairs Officer for Siemens Shanghai Medical Equipment Ltd., you will ensure our medical products and processes comply with international and national standards and regulations. This includes taking responsibility for product registration, ensuring compliance with relevant laws and regulations, and coordinating market...
-
Regulatory Affairs Expert
2 months ago
Shanghai, Shanghai, China Siemens Healthineers Ltd. Full timeAbout the Role:We 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 be responsible for championing the definition, alignment, and adoption of product design characteristics, practices, and outcomes with cross-functional stakeholders to enable the most...
-
Medical Device Regulatory Affairs Specialist
1 month ago
Shanghai, Shanghai, China Siemens Healthineers Ltd. Full timeKey ResponsibilitiesAs 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:Champion the...
-
SSME MOE Senior Strategy Specialist
4 months ago
Shanghai, China Siemens Shanghai Medical Equipment Ltd. Full timeJoin us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your...
-
Assistant Manager, Regulatory Affairs
6 months ago
Shanghai, China L'Oréal Full timeManage APAC regulatory compliance projects on both cosmetic ingredient and finished product to support R&I innovations. Develop robust compliance solutions with cosmetic, chemical and other possible related area regulatory expertise, risk assessment and recommendation, to both upstream and downstream innovation projects led by APAC R&I hubs and coming to...