Senior Regulatory Affairs

**Job Description**:
Job Title

Senior Regulatory Affairs

Collaborate with Innovative 3Mers Around the World

Choosing where to start and grow your career has a major impact on your professional and personal life, so it’s equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a diversity of people, global locations, technologies and products, 3M is a place where you can collaborate with 96,000 other curious, creative 3Mers.

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 global regulatory requirements and paths to support achievement of business objectives.
- Prepare Standard Technical Documentation packages for Consumer Health products for use in international medical device registrations
- Assure that all drug, device, and establishment listings for Consumer Health products are accurate and up to date
- Advise on new regulatory strategies to address ‘new to the world’ development programs and assess ease of regulatory approval in various markets to help business prioritization of market opportunities. Identify risks and develop mitigation plans
- Prepare certificates for international government registration needs, including preparation of Country or region-specific Declarations of Conformity for products
- Review product labeling and claims for compliance to applicable regulations
- Represent Regulatory Affairs on multidisciplinary project teams including New Product Introductions
- Ensure compliance with applicable regulatory requirements including those pertaining to product safety and post-market surveillance / vigilance
- Address product changes in regulatory documentation

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’s degree or higher (completed and verified prior to start) from an accredited institution
- Three (3) years of combined experience in Regulatory Affairs in a private, public, government or military environment

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

- Regulatory Affairs experience in one or more of the following areas: combination products, medical devices, medical device components, cosmetics and/or over the counter drugs
- Understanding of device and drug regulations, with experience with FDA and international submissions
- 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

Work location: Hybrid Eligible (Job Duties allow for some remote work but require travel to the 3M Center at least 2 days per week)

Travel: May include up to 5% 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

3M offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope.

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