Global Regulatory Affairs Professional

4 weeks ago

Shanghai, Shanghai, China 3M Full time
Regulatory Affairs Specialist

At 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 Role

This role offers the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Primary responsibilities include:

  • Providing 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.
  • Preparing Technical Documentation for Consumer Health products for use in China.
  • Assuring that all device listings, import licenses, and registrations for Consumer Health products are accurate and up-to-date.
  • Advising on new regulatory strategies.
  • Reviewing product labeling and claims for compliance to applicable regulations.
  • Representing Regulatory Affairs on multidisciplinary project teams including New Product Introductions and Change Management Projects.
  • Providing local QMS, Distribution Quality assistance, audit support as required.
  • Interface with local agencies.
  • Participating and providing support within GCA Regulatory.
  • Ensuring compliance with applicable regulatory requirements including those pertaining to product safety and post-market surveillance/vigilance.
  • Addressing product changes in regulatory documentation.
  • Assisting with other Asia-related regulatory tasks as assigned.

Your Skills and Expertise
To succeed in this role from day one, 3M requires the following qualifications:

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

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 skills.

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 the ability to provide diligent, concise, and fact-based communication to Executive Management and cross-functional peers.

Proficient in Microsoft Office Tools.

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