Regulatory Specialist, Critical and Chronic Care Solutions Division (Maplewood, MN)
Maplewood , Minnesota
December 12, 2017
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Job Description:

3M is seeking a Regulatory Affairs Specialist in the Critical and Chronic Care Solutions Division located in Maplewood, MN

Job 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

Basic Qualifications:
  • 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

Preferred Qualifications:
  • 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

Location: Maplewood, MN
Travel: May include minimal travel
Relocation Benefits: Are not authorized for this position

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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.

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