Regulatory Affairs Specialist

4 weeks ago

Shanghai, Shanghai, China 3M Full time

Job Title: Regulatory Affairs Specialist - China Market Access

The Impact You'll Make in this Role

As a Regulatory Affairs Specialist, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Primary Responsibilities include but are not limited to the following:

  • Provide support and expertise as part of the Regulatory organization using knowledge of China regulatory requirements and paths to ensure market access and right to operate
  • Prepare Technical Documentation for Consumer Health products for use in China
  • Assure that all device listings, import licenses, and registrations for Consumer Health products are accurate and up to date
  • Advise on new regulatory strategies
  • Review product labeling and claims for compliance to applicable regulations
  • Represent Regulatory Affairs on multidisciplinary project teams including New Product Introductions and Change Management Projects
  • Provide local QMS, Distribution Quality assistance, audit support as required
  • Interface with local agencies
  • Participate and provide support within GCA Regulatory
  • Ensure compliance with applicable regulatory requirements including those pertaining to product safety and post-market surveillance / vigilance
  • Address product changes in regulatory documentation
  • Assist with other Asia related regulatory tasks as assigned

Your Skills and Expertise

To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:

Bachelor degree or higher (completed and verified prior to start) from an accredited institution with relevant technical degree.

Ten (10) years of combined experience in Regulatory Affairs and/or regulated R&D in a private, public, government or military environment. High preference for experiences in consumer medical device and/or cosmetic product registrations. Expertise in product specific regulatory and standard requirements for China registration.

Ability and experience in interfacing with regulatory agencies and testing agencies in China

Demonstrable effective cross-functional and intercultural working experiences in a global company.

Good English speaking skillsets

Demonstrated ability to support technical efforts, with proven experience collaborating effectively with cross functional team members

Ability to multi task and prioritize personal workload to meet deadlines

Strong verbal and written communication skills with ability to provide diligent, concise and fact based communication to Executive Management and cross functional peers

Proficient in Microsoft Office Tools

  • Regulatory Affairs Specialist

    2 weeks ago

    Shanghai, Shanghai, China PSI Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:PSI is seeking a highly skilled Regulatory Affairs Specialist to facilitate the start of research projects for novel medicinal products. This role is ideal for a motivated individual with a strong understanding of registration regulations and procedures in NMPA, CDE, NIFDC, HGRAC, and ICH guidelines.Main...

  • Regulatory Affairs Specialist

    4 weeks ago

    Shanghai, Shanghai, China PSI Full time

    Job Title: Regulatory Affairs SpecialistJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at PSI. The successful candidate will be responsible for facilitating the start of research projects of novel medicinal products, while taking a step further in their professional career.Key Responsibilities:Monitor new...

  • Regulatory Affairs Specialist, International Markets

    3 weeks ago

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

    About the Role:Hydrafacial Trading (Shanghai) Co Ltd (China) is seeking a highly skilled Regulatory Affairs Specialist to join their team. As a key contributor, you will play a vital role in bringing the company's products into new markets and spearheading global medical device/cosmetic regulatory submissions.Key Responsibilities:Lead all regulatory affairs...

  • Regulatory Affairs Manager

    1 month ago

    Shanghai, Shanghai, China Nu Skin Full time

    About the Role:Nu Skin is seeking a highly skilled Regulatory Affairs Manager to oversee regulatory projects for our China operations. As a key member of our Regulatory Affairs Department, you will play a critical role in ensuring compliance with various regulations related to food and food supplements, electronic devices, and cosmetics.Key...

  • Senior Regulatory Affairs Specialist

    4 weeks ago

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

    As a Senior Regulatory Affairs Specialist at Siemens Shanghai Medical Equipment Ltd., you will play a crucial role in ensuring our medical devices comply with international and national standards and regulations. Your expertise will be essential in product registration and maintaining market clearance.Key responsibilities include:Ensuring product and process...

  • Regulatory Affairs Specialist

    4 weeks ago

    Shanghai, Shanghai, China International Flavors & Fragrances Full time

    Job SummaryWe are seeking a highly motivated and results-driven individual to join our Asia team as Manager, Regulatory Affairs in China. This role reports to the Head of Greater China Regulatory Affairs and will preferably be located in Shanghai, China.Your Key ResponsibilitiesRegistration and compliance of IFF Nourish flavors used in food and...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    Shanghai, Shanghai, China Nu Skin Full time

    About 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

    4 weeks ago

    Shanghai, Shanghai, China DSM Full time

    Key Responsibilities:As a Regulatory Affairs Specialist at DSM, you will play a crucial role in launching our new Taste business. Your key responsibilities will include:1. Facilitating and Supporting the Introduction of Local RMs:* Oversee the introduction of local raw materials, including but not limited to seasoning raw materials (SSN RMs).* Collaborate...

  • Regulatory Affairs Specialist for Medical Devices

    2 days ago

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

    We 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...

  • Global Regulatory Affairs Professional

    3 days ago

    Shanghai, Shanghai, China 3M Full time

    Regulatory 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 Affairs Director

    4 days ago

    Shanghai, Shanghai, China Abbott Full time

    Company 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...

  • Regulatory Affairs Manager

    4 weeks ago

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

    Job SummaryHydrafacial Trading (Shanghai) Co Ltd (China) is seeking a highly skilled Regulatory Affairs Manager to join our team. As a key contributor, you will play a crucial role in bringing our products into new markets and spearheading global medical device/cosmetic regulatory submissions.Key ResponsibilitiesLead all regulatory affairs transactions...

  • Regulatory Affairs Expert

    4 weeks ago

    Shanghai, Shanghai, China Siemens Healthineers Ltd. Full time

    About 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...

  • Regulatory Affairs Manager

    1 month ago

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

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Hydrafacial Trading (Shanghai) Co Ltd (China). As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements in APAC and China.Key ResponsibilitiesDevelop and implement regulatory strategies to ensure compliance...

  • Regulatory Affairs Manager

    1 day ago

    Shanghai, Shanghai, China Abbott Full time

    About the Role">We are seeking a highly skilled Regulatory Affairs Manager - Product Registration Specialist to join our team at Abbott. In this critical role, you will be responsible for providing regulatory input to supervisors for decision-making on registration filing strategies.Key Responsibilities">Set up product registration timelines and ensure their...

  • Medical Device Regulatory Affairs Specialist

    2 weeks ago

    Shanghai, Shanghai, China Siemens Healthineers Ltd. Full time

    Key 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...

  • Regulatory Affairs Specialist

    3 days ago

    Shanghai, Shanghai, China PSI Full time

    Company 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...

  • Senior Regulatory Affairs Lead

    3 weeks ago

    Shanghai, Shanghai, China Abbott Full time

    Job 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...

  • Global Regulatory Compliance Specialist

    3 weeks ago

    Shanghai, Shanghai, China 3M Full time

    About the Role3M is a pioneer in innovation and a leader in the industry. As a Regulatory Affairs Specialist, you will have the opportunity to work with a diverse team and contribute to the success of our Consumer Health products in the China market.ResponsibilitiesProvide expertise and support to the Regulatory organization in understanding China regulatory...

  • Regulatory Affairs Expert

    2 weeks ago

    Shanghai, Shanghai, China International Flavors & Fragrances Full time

    Job SummaryWe are seeking a highly motivated and results-driven Regulatory Affairs Expert to join our Asia team in China. As a key member of our regulatory team, you will play a critical role in ensuring compliance with regulatory requirements for our flavor and fragrance products.Your Key ResponsibilitiesRegistration and ComplianceSupport the registration...