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.Job Description:3M is seeking a Regulatory Affairs Specialist in the Critical and Chronic Care Solutions Division located in Maplewood, MNJob Summary
The person hired for the Regulatory Affairs Specialist position will provide regulatory leadership and be part of a global team that drives growth; enables accelerated product development; supports compliance and regulatory requirements worldwide; and improves operational excellence by supporting special regulatory assignments, training, and interpretation of changes in the regulatory environment.Primary Responsibilities
include but are not limited to the following:
- Provide regulatory leadership on global business team or new product team(s)
- Develop product registration strategies globally that enable accelerated product development through knowledge of FDA regulations, EU Directives, ISO standards, etc.
- Prepare regulatory documents (summary technical documents, essential requirements checklists, 510(k)'s, Biologic License Applications, EU design dossiers) as needed
- Provide support on special regulatory assignments relating to the development of internal procedures, training, interpretation of existing and new international regulations
- Plan and execute global product registrations on time
- Assure regulatory compliance in all activities
- Bachelor's degree or higher in a Science or Engineering discipline from an accredited Institution
- Minimum of four (4) years of regulatory affairs experience
- Regulatory Affairs experience in one or more of the following areas: combination products, biological products, and/or medical devices
Location: Maplewood, MNTravel: May include minimal travelRelocation Benefits: Are not authorized for this position
- Bachelor's degree or higher in Pharmacy, Engineering, Biological Sciences, Chemistry or related discipline from an accredited University
- RAC certification
- Five (5)+ years of regulatory experience interacting with FDA and/or other regulatory bodies worldwide
- Demonstrated technical/scientific skills, excellent technical communication skills (oral and written), effective interpersonal and organizational skills and the ability to meet deadlines
- Demonstrated history of accomplishments and contributions to business in previous assignment in support of regulated products
- Proven project leadership and excellent communication skills
- Knowledge of or experience with tissue and/or biologic regulations
- Bilingual (English and Spanish or Chinese-Mandarin) a plus
- Microsoft Office proficient
Learn more about 3M's creative solutions to the world's problems at www.3M.com or on Twitter @3M or @3MNewsroom.
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A little about us:
Innovation is a way of life at 3M. We solve problems by applying creativity, team work and ingenuity to improve life for millions of people worldwide.