Regulatory Specialist

4 weeks ago

London, Canada 3M Full time

**Job Description**:
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 other curious, creative 3Mers. 3M is seeking a Regulatory Specialist for its Consumer Health Care team located Canada.

This position provides an opportunity to transition from other private, public, government or military environments to a 3M career.

The Impact You’ll Make in this Role

As a Regulatory 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. Here, you will make an impact by:

- Lead/coordinate regulatory strategy for Canada
- Provide support and expertise as part of the Regulatory organization using knowledge of Canada regulatory requirements and paths to support achievement of business objectives.
- Prepare Technical Documentation for Consumer Health products
- Assure that all device listings, import licenses, establishment 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 or Distribution Quality assistance as required
- Interface with local agencies
- Ensure compliance with applicable regulatory requirements including those pertaining to product safety and post-market surveillance / vigilance
- Address product changes in regulatory documentation
- Support other global needs including USAC design center support

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 in STEM (science, technology, engineering and/or mathematics) discipline (completed and verified prior to start)
- Five (5) years of regulatory or compliance experience including Working knowledge of Canada Medical Device Regulations experience in a private, public, government or military environment

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

- Bachelor's degree or higher in Biological Sciences (completed and verified prior to start) from an accredited institution
- ISO 13485 experience
- Prefer both English and French fluency
- Medical Device Post Market experience
- Experience working with Health Canada
- Experience conducting marketing and labeling reviews
- Excellent communication skills and attention to detail

Work location:

- Hybrid or Remote Eligible

Travel: May include up to 10% domestic / international

Relocation Assistance: Is not 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.

Chat with Max

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.

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