At 3M, we apply science in collaborative ways to improve lives daily. With $30 billion in sales, our 90,000 employees connect with customers all around the world.
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.
3M is seeking a Regulatory Affairs Manager for the Critical and Chronic Care Solutions Division located in Maplewood, MN. Be part of what’s next!
The Regulatory Affairs Manager will have global responsibility for development and execution of regulatory strategies for new products and marketed products for the Critical and Chronic Care Solutions Division (C3SD).
Primary Responsibilities include but are not limited to the following:
Provide Regulatory options for Business Strategies for medical device, device/drug combination product development activities Use knowledge of regulatory paths to set direction for each program while meeting business needs Assess ease of regulatory approval in various markets and help business prioritize market opportunities Identify risks and develop mitigation plans Create new regulatory strategies to address ‘new to the world’ development programs
Determine Regulatory strategy for marketed products changes Implement changes efficiently while maintaining business continuity worldwide Champion new processes to meet changing regulatory requirements
Stakeholder Management Integrate needs of global business team into operational plans Identify Regulatory opportunities for business Strategic Planning Engage Regulatory agencies on policy issues important to the business Interact with other Health Care divisions within 3M to ensure alignment
Supervision Coach and develop direct reports to reach fullest potential Develop budget and resource plan to meet work load while maintaining stretch Conduct Health of the Organization planning for future business needs Identify and manage outside consultants as needed
- Bachelor's degree or higher in Biology, Chemistry, Chemical Engineering or related discipline from an accredited institution
- Minimum of five (5) years regulatory experience
- Understanding of quality systems requirements for medical device, drug/device combination products and HCT/Ps
- Detailed oriented, ability to navigate matrix environment
Location: Maplewood, MN
Travel: May include up to 5% domestic and international
Relocation: Is not authorized