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Senior Regulatory Affairs Specialist

2 months ago

Minneapolis, Minnesota, United States Abbott Laboratories Full time
Job Title: Senior Regulatory Affairs Specialist

Abbott Laboratories 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.

We are seeking a passionate and experienced Senior Regulatory Affairs Specialist to join our team on-site in Plymouth, or St. Paul, MN. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You will provide regulatory guidance to cross-functional partners in support of various programs.

Key Responsibilities:
  • Prepares robust regulatory applications to achieve departmental and organizational objectives.
  • Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team.
  • Provides guidance and expertise on complex worldwide strategies with the help of international regulatory affiliates.
  • Compile, prepare, review, and submit medical device submissions to regulatory agencies.
  • Interfaces directly with FDA and other regulatory agencies.
  • Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements worldwide are current and up-to-date.
  • Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
  • Reviews device labeling for compliance with FDA submissions and applicable regulations.
  • Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
  • Conducts reviews of product and manufacturing changes for compliance with applicable commercial and clinical regulations.
  • Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
Requirements:
  • Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
  • Minimum 2 yrs. regulatory experience and/or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function.
  • Preferred qualifications include 4+ years of related regulatory submission experience from medical device, pharmaceutical, or healthcare industry, advanced level degree, Class II or Class III medical device experience, experience with PMA supplements, 510(k) applications, and US device regulations and/or experience with EU and other international medical device regulations and submissions.

Abbott Laboratories is an Equal Opportunity Employer, committed to employee diversity. We offer a competitive salary range of $72,700.00 – $145,000.00, depending on location. If you are passionate about regulatory affairs and want to make a difference in the healthcare industry, apply now