Senior Regulatory Affairs Specialist

6 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 delivering high-quality products and services that improve the health and well-being of people around the world.

The Opportunity

We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. In this role, you will be responsible for leading the preparation and submission of regulatory approvals and identifying and resolving problems.

Key Responsibilities
  • Prepares robust regulatory applications to achieve departmental and organizational objectives.
  • Acts as a regulatory representative on core product development teams, communicating 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 world-wide are current, up-to-date and are entered into regulatory submission data base and file systems.
  • 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.
  • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
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: 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.
What We Offer

We offer a competitive salary and benefits package, including medical coverage, retirement savings plan, tuition reimbursement, and education benefits.

We are an equal opportunity employer and welcome applications from diverse candidates.

Please apply through our website or contact us at [insert contact information].

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