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Senior Regulatory Affairs Associate

Employer
3M
Location
Minnesota
Salary
Competitive

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Job Description:

3M is seeking a Senior Regulatory Affairs Associate for the Oral Care Solutions Division (OCSD) located in Maplewood, MN . At 3M, you can apply your talent in bold ways that matter. Here, you go.

Job Summary :

The person hired for the position of Senior Regulatory Affairs Associate will provide regulatory support to marketed device product teams with a focus on Dental and Orthodontic medical device products.

For additional information, please visit:

This position provides 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:

  • Provide regulatory support and guidance to assigned device product teams.
  • Determine regulatory pathway and provide complete global regulatory assessment of product changes, including submission of 510(k) packages, as appropriate.
  • Coordinate and lead teams in the compilation and submission of 510(k) premarket notifications, international registration dossiers and technical files.
  • Provide regulatory support for international registrations and requests for documentation, and support for registration of portfolio products in new markets.
  • Support efforts of European Union (EU) Medical Device Regulation (MDR) compliance.
  • Determine regulatory pathways and provide global regulatory assessments for product changes.
  • Input into requirements for medical device labeling, advertising, and approve final versions.
  • Support international registrations, re-registrations and requests for documentation.
  • Support on-going projects related to new and changing global regulations.
  • Basic Qualifications:

  • Possess a Bachelor's degree or higher in a science or engineering discipline (completed and verified prior to start) from an accredited institution
  • Minimum three (3) years of Regulatory Affairs, Laboratory and/or Quality experience in a regulated environment (private, public, government or military)
  • Preferred Qualifications:

  • Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS)
  • Understanding of medical device regulations and quality systems
  • Experience in medical device product design and support
  • Strong communications skills (oral, written and presentation)
  • Experience contributing on a global cross-functional team
  • Microsoft Office proficient. Software programming and cyber security experience a plus
  • Location : Maplewood, MN

    Travel: Up to 5% domestic/international

    Relocation: Is not authorized

    Learn more about 3M's creative solutions to the world's problems at or on is an equal opportunity employer. 3M will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status.

    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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  • Posted Yesterday
  • Full time
  • R
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