Regulatory Affairs Supervisor,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: 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
As a Regulatory Affairs Supervisor you will have the opportunity to lead our registration projects, responsible for managing the registration process for domestic medical devices as well as maintaining post-market product registrations.

• Registration Leadership: Develop detailed regulatory strategies and timelines for the registration process. Familiarity with clinical evaluation pathways. Provide regulatory assessment for NPI projects. Review and manage regulatory submission documents. Lead communications with testing institutions and regulatory authorities.
• Post-Market Registration Maintenance: Provide regulatory support for post-market production and sales activities. Lead the change and renewal processes for existing product licenses. Ensure product labels and IFU comply with regulatory requirements.
• System and Audit Support: Familiar with ISO 13485 to support internal and external audits, ensuring the registration process compliance. Provide regulatory perspectives for addressing audit findings.
• Cross-Functional Collaboration: Work closely with internal cross-functional teams (R&D, Quality, Production, Clinical, etc.) to ensure the timely completion and high quality of registration documents.
• Regulatory Monitoring and Strategy Adjustment: Monitor and interpret the latest medical device regulations and standards, assess their impact, and take actions to ensure compliance.

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 or higher AND 3-5 years of experience in regulatory affairs for domestic/imported medical devices.

In addition to the above requirements, the following are also required:

• 3-5 years of experience independently managing the full lifecycle registration of Class II or III passive medical devices.
• 3-5 years of experience in supporting internal/external audit.
• Good communication and collaboration skills. Strong project management and leadership abilities.
• English communication in speaking, listening and writing. Additional qualifications that could help you succeed even further in this role include:
• Master's degree in Biology, Materials, Chemistry, Medicine, or a related field from an accredited institution
• More than 5 years of Regulatory Affairs experience in medical device manufacturing company
• Working experience in multinational company.
• ISO 13485 Internal Auditor Certification.

Work location:

• 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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