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Project Manager, Regulatory Affairs

Employer
Abbott Laboratories
Location
Saint Paul
Salary
Competitive

View more

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 109,000 colleagues serve people in more than 160 countries.

Project Manager, Regulatory Affairs- St. Paul, MN

ABOUT ABBOTT

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of STRUCTURAL HEART disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.

WHAT YOU'LL DO

We are recruiting for a Program Manager, Regulatory Affairs to join our team in the St. Paul MN location. You will be supporting Abbott's exciting and growing Transcatheter Aortic Valve Implantation (TAVI) product lines. In this role, you will be responsible for regulatory strategy, US/EU regulatory submissions for existing and new TAVI products in development. You will be the regulatory lead in cross-functional teams through planning, execution, submissions, questions and responses, and market release of new and modified TAVI products. You will assess product/manufacturing changes for regulatory impact in global geographies prior to implementation.

Responsibilities:

  • Prepare US PMA and EU MDR submissions for modified and new TAVI devices.

  • Ensure testing plans to qualify changes are appropriate for submissions and meet local requirements of US/EU and other international geographies.

  • Working with Regulatory Affairs staff, engineers and technical experts to resolve potential regulatory issues, deficiencies and questions from regulatory agencies.

  • Represent regulatory in cross-functional meetings to provide direction.

  • Reviewing and approving design, labeling or manufacturing changes for implantable medical devices and preparing necessary regulatory documents to support changes.

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

  • Providing direct temporary help in heavy work situations.

  • Complying with 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.

  • Mentoring junior regulatory affairs staff.

  • Other duties as assigned.

EDUCATION AND EXPERIENCE YOU'LL BRING

Required

  • Bachelor's degree

  • 8+ years of experience in a similar role within the medical device industry, including US, EU (MDD/MDR) submission experience

  • Ability to work in a highly matrixed and geographically-diverse business environment

  • Demonstrated leadership skills and experience, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results

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

  • Ability to travel up to approximately 15%

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

Preferred

  • Advanced degree

  • Demonstrated Experience working with technical documentation

  • Significant experience with US, EU and other international medical device regulations and submissions

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

  • Training and career development, with onboarding programs for new employees and tuition assistance

  • Financial security through competitive compensation, incentives and retirement plans

  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

  • Paid time off

  • 401(k) retirement savings with a generous company match

  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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