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Abbott Senior Regulatory Affairs Specialist in St. Paul, Minnesota

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 103,000 colleagues serve people in more than 160 countries.

Position Summary:

We are currently recruiting for a Senior Regulatory Affairs Specialist to join our team in the St. Paul, MN location. In this position, you will lead the preparation and submission for regulatory approvals and provide regulatory guidance to cross-functional partners. You will focus on US and EU submissions, including PMA and IDE, change management for product design changes, as well as product development projects. The products covered are trans-catheter aortic valves and related delivery systems.

Primary Responsibilities:

  • Prepares robust regulatory applications to achieve departmental and organizational objectives.

  • Creates, reviews and approves engineering change orders

  • 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

  • Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail

  • 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 and marketing materials for compliance with FDA submissions and applicable regulations.

  • Interfaces directly with FDA and other regulatory agencies

  • Supports the product release process by reviewing and approving requests for product release.

  • Conducts reviews of product and manufacturing changes for compliance with applicable regulations.

  • Reviews 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

  • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments

  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

  • Provides mentoring and leadership to Regulatory Specialist I and II team members

  • Performs other related duties and responsibilities, on occasion, as assigned

Required Qualifications:

  • Bachelor’s Degree

  • 4+ years of medical device experience working with regulatory affairs experience, including experience with 510(k) applications, PMA supplements, US device regulations

  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

  • Ability to identify and solve problems and work independently with little oversight

  • Previous experience working in a highly matrixed and geographically diverse business environment

Preferred Qualifications:

  • Advanced Degree in a technical discipline (i.e. in any of the Sciences)

  • Experience with EU and other international medical device regulations and submissions

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

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