3M 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 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.
- Expertise in product specific regulatory and standard requirements in China registration, including E-commerce regulations and business models.
- Ability and experience in interfacing with regulatory agencies and testing agencies in China
- Experience as quality / safety officer or in quality management is a big plus
- 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
Learn more about 3M’s creative solutions to the world’s problems at www.3M.com or on Twitter @3M.
Our approach to flexibility is called Work Your Way, which puts employees first and drives well-being in ways that enable 3M’s business and performance goals. You have flexibility in where and when work gets done. It all depends on where and when you can do your best work.
Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly.
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