Regulatory Affairs Specialist,Shanghai

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers’ toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Job Description

3M Health Care is now Solventum

At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you.

The Impact You’ll Make in this Role

The person hired for the position of Regulatory Affairs Specialist will assume responsibility for supporting the regulatory project, and managing the product registrations, license maintenance, license renew and provide regulatory support to ensure compliance in GCA.

As a Regulatory Affairs Specialist, you will have the opportunity to collaborate with some of the most innovative and diverse people around the world. Here you will make an impact by:

• To manage medical device registrations and filings with health authorities including documents preparation, internal and external communications in CHK.
• To maintain and manage registration information system to ensure data accuracy.
• To support UDI implementation in CHK, including uploading UDI data into NMPA UDI database.
• As the coordinate for the Rebranding contact person in GCA, to work with cross functions of the rebranding projects.
• As the NOVA CHK project super user for Regulatory Affairs, to transfer the license data from the current system to the NOVA CHK system smoothly, provide system related trainings to Regulatory team.
• To provide regulatory supports to cross functions to keep compliance.
• To complete other tasks assigned by supervisor. 

Your Skills and Expertise 

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

• Bachelor’s degree in material, engineering, biotechnology, pharmacy, or related subject;
• At least 3 years of experience as regulatory affairs role in medical device , pharmaceutical, or health care industry.
• English communication in speaking, listening and writing;
• Good communication skills.

Additional qualifications that could help you succeed even further in this role include:

• Sound knowledge of HK regulatory environment and regulations.
• Excellent computer literacy, good interpersonal, communication and project management skills.
• Team player with high degree of integrity and responsibility. Organized, detail-minded and flexible.

Work location: Shanghai

• Hybrid Eligible (Job Duties allow for some remote work but require travel to location at least 3 days per week)

Travel:

May include up to 10% domestic/international

Relocation Assistance: May be authorized Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). Supporting Your Well-being Solventum offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope.

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