Regulatory Affairs Associate

23 Feb, 2021

Jobs

Regulatory Affairs Associate

3M
San Antonio, TX/Saint Paul, MN

Job Description:

Regulatory Affairs Associate

Collaborate with Innovative 3Mers Around the World

Choosing where to start and grow your career has a major impact on your professional and personal life, so it’s equally important you know that the company that you choose to work at, and its leaders, will support and guide you. With a diversity of people, global locations, technologies and products, 3M is a place where you can collaborate with 93,000 other curious, creative 3Mers.

This position provides an opportunity to transition from other private, public, government or military environments to a 3M career.

“One of the best parts of my job is feeling the impact of 93,000 3Mers collaborating around the world and seeing the difference they’re able to make in people’s lives.” – Julie Bushman, executive vice president of International Operations at 3M

The Impact You’ll Make in this Role
The person hired for this regulatory affairs associate position will provide regulatory support to marketed device product teams.  Providing regulatory support, strategy and guidance for new medical products which may include devices, drugs and/or biologics (on product development teams)

As a Regulatory Affairs Associate, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by:

  • Prepares submissions and compiles documentation in support of domestic and international product marketing approvals.  Regulatory submissions may be related to new products, new intended uses for existing products, and introduction of existing products into new geographies.
  • Reviews proposed modifications to intended use, design, labeling, materials, and manufacturing processes to assess impacts existing regulatory   approvals/ clearances   Works with teams to develop strategies and plans to manage the implementation of changes.
  • Reviews Engineering Changes and provide input outlining impacts to existing and in-process regulatory approvals/clearances.
  • Maintains open communications with local country representatives, including distributors, in-country RA and local regulatory agencies as required.
  • Read and understand global regulations and provide regulatory advice, as required.
  • Reviews product labeling and promotion materials to assure compliance with regulations and approvals.
  • Prepares and maintains regulatory files and tracking databases.
  • Provides effective communication to project teams regarding new regulations, policies and initiatives that could impact products and processes.
  • Assists with preparation for and participate in regulatory agency audits

Your Skills and Expertise 

To set you up for success in this role from day one, 3M requires (at a minimum) the following qualifications:

  • Bachelor’s degree or higher in a life science, engineering, or related field or higher (completed and verified prior to start) from an accredited institution.
  • Three (3) years device regulatory affairs experience or device experience in a related function (i.e., laboratory, quality, pharmaceuticals) in a private, public, government, or military environment.

Additional qualifications that could help you succeed even further in this role include:

  • Basic understanding of FDA device regulations
  • Knowledge of global medical device regulations
  • Strong written and oral communication/presentation skills
  • Ability to work effectively in cross functional teams

Location: San Antonio, Texas

Travel: May include up to 5%, domestic and international

Relocation: Relocation may be authorized

Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status).

Supporting Your Well-being

3M offers many programs to help you live your best life – both physically and financially. To ensure competitive pay and benefits, 3M regularly benchmarks with other companies that are comparable in size and scope.

Resources for You

For more details on what happens before, during and after the interview process, check out the Insights for Candidates page at 3M.com/careers. 

Learn more about 3M’s creative solutions to the world’s problems at www.3M.com or on Twitter @3M.Responsibilities of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties.3M 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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Job posted: 2021-02-23