Regulatory Affairs Specialist
3M Health Information Systems
Job Description:
Regulatory Affairs Specialist
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 wide variety of people, global locations, technologies and products, 3M is a place where you can collaborate with 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 people around the world. The person hired for this position in the 3M Consumer Healthcare Business within Consumer Business Group will make an impact by:
• Serving as Functional Subject Matter Expert
• Lead/coordinate medical device and cosmetic regulatory affairs for part of the US designed portfolio
• Coordinate communication and compliance globally
• Support international requests
• Support new product introductions and existing product changes
• Conduct global regulatory assessments and partner to determine global strategy
• Participate in audits; champion compliance
• Support product licenses, establishment licenses, etc
• Ensure market access and right to operate
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
• Experience in Regulatory Affairs in Medical Devices
• Advanced English Speaking and Writing Competency
Additional qualifications that could help you succeed even further in this role include:
• Advanced Degree
• Regulatory Affairs Certificate (RAC)
• Medical Device Regulatory Affairs experience with FDA
• EU Medical Device Regulation experience
• Ability to interface with regulatory agencies and support audits
• Demonstrated communication skills, must be able to summarize and articulate technical/regulatory information to diverse audiences both verbally and in writing in English
• Cosmetic Regulatory Experience
• Ability to work cross functionally across a global organization
• Excellent organizational skills, attention to detail
• Ability to work with different cultures and cross functional teams
• Experience leading programs without significant oversite
• Proficient in Microsoft Office Tools
Work location:
• Work location: This role follows an on-site working model, requiring the employee to work at least four days a week at the Sumaré, Brazil site.
• Flex hours to accommodate USA team time zone
• Travel: May include up to 5% domestic/international
• Relocation: Not authorized
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
For assistance with searching through our current job openings or for more information about all things 3M, visit Max, our virtual recruiting assistant on 3M.com/careers.
Grade:
T4
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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