Senior Regulatory Affairs Associate (Maplewood, MN)MAPLEWOOD, Minnesota, USALaboratory/Technical and SoftwareR00977173
3M is seeking a Senior Regulatory Affairs Associate for the Health Care Business Group (HCBG) with the position located in Maplewood, MN
The person hired for the position of Senior Regulatory Affairs Associate will be responsible for development and execution of regulatory strategies for the 3M Health Care Business Group with a specific assignment in the Oral Care Division.
For additional information, please visit: : https://www.3m.com/3M/en_US/oral-care-us/
This position offers an opportunity to transition from other private, public, government or military environments to a 3M career.
Primary Responsibilities include but are not limited to the following:
- Providing regulatory leadership on global business teams or new product teams
- Developing product registration strategies globally that enable accelerated product development through knowledge of Food and Drug Administration (FDA) regulations, European Union (EU) Directives/Regulations, International Organization for Standardization (ISO) Standards, etc.
- Preparing regulatory documents (summary technical documents, 510(k)s, technical files, declarations of conformity, etc.
- Assess changes to marketed products for impact to regulatory compliance and product safety
- Coordinate global regulatory strategy with subsidiaries
- Providing support for special regulatory assignments relating to the development of internal procedures, training, interpretation of existing and new regulations
- Possess a Bachelor’s degree or higher in a Science or Engineering discipline (completed and verified prior to start) from an accredited institution
- Minimum four (4) combined years of regulated medical product (device, drug, biologic) experience working in regulatory affairs, laboratory and/or quality (private, public, government or military)
- Master’s degree or higher from an accredited institution
- Minimum six (6) years of regulated medical product (device, drug, biologic) experience working in regulatory affairs, laboratory and/or quality (private, public, government or military)
- Direct, first-hand experience leading both U.S. and Global registration of novel medical products including devices, drugs and/or biologics
- Experience with 510(k) submissions and CE Marking
- Broad medical product regulatory experience including devices, drugs and/or biologics
- Understanding of medical device regulations and/or quality systems
- Experience in medical product design and/or support
- Experience with global medical product registration
- Detail oriented, ability to navigate matrix environment
- Leadership capabilities and a team-player
- Strong communications skills (oral, written and presentation)
- Experience working on a global cross-functional team
- Microsoft Office proficient
Location: Maplewood, MN
Travel: May include up to 5% domestic
Relocation: Is not authorized
3M is a place where you can collaborate with other curious, creative people. Where your diverse talents, inclusiveness, initiative, and leadership are valued. Where you’ll find challenging opportunities that make your career exciting and rewarding. With a diversity of people, global locations, technologies, and products, 3M is a place to grow and be rewarded for excellence.
Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).