Regulatory Affairs Specialist II

5 days ago

Minneapolis, Minnesota, United States Abbott Laboratories Full time
About Abbott Laboratories

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.

Our Mission

We are committed to helping people live their best lives by providing innovative solutions that improve health outcomes and enhance quality of life.

The Opportunity

We are seeking a highly skilled Regulatory Affairs Specialist II to join our team in Plymouth, MN. In this role, you will be responsible for ensuring that our medical devices comply with regulatory requirements and are registered with the relevant authorities.

Key Responsibilities

  • Prepare and submit regulatory applications, including annual reports, to achieve departmental and organizational objectives.
  • Create, review and approve engineering changes to ensure compliance with regulatory requirements.
  • Act as a regulatory representative, responsible for review and analysis of applicable regulatory guidelines.
  • Review and evaluate communications to ensure they convey all necessary detail and adhere to applicable regulatory standards.
  • Maintain pertinent domestic and international medical device regulations to ensure submission requirements are current and up-to-date.
  • Support the product release process by creating GTS licenses or reviewing and approving requests for product release.
  • Interface directly with regulatory agencies, as needed.
  • Review protocols and reports to support regulatory submissions.
  • Support all Company initiatives, as identified by management, and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Requirements

  • Bachelor's degree (or equivalent) in a relevant field, such as science, engineering, or medical technology.
  • 2-3 years' experience in a regulated industry, preferably in a regulatory role.
  • Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
  • Strong verbal and written communication skills, with the ability to effectively communicate at multiple levels in the organization.

Preferred Qualifications

  • Certification in regulatory affairs, such as RAC from the Regulatory Affairs Professionals Society.
  • Proficient with MS Office suite (Word, Excel, Outlook).

What We Offer

  • A competitive salary range of $57,300.00 – $114,700.00, depending on location.
  • A comprehensive benefits package, including medical, dental, and vision coverage.
  • A 401(k) retirement savings plan with high employer contribution.
  • Tuition reimbursement and education assistance programs.
  • A dynamic and supportive work environment, with opportunities for growth and development.

How to Apply

If you are a motivated and detail-oriented individual with a passion for regulatory affairs, please submit your application, including your resume and cover letter, to our website.

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