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

Senior Regulatory Affairs Specialist (New Product Development) – Little Canada/St Paul, MN

Leading an active lifestyle is important to the many people we serve. In Abbott’s Electrophysiology and Heart Failure (EPHF) division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives.

The Senior Regulatory Affairs Specialist is responsible for planning and executing global regulatory activities necessary to obtain and maintain regulatory approvals within the United States and Europe. This position is also responsible for the regulatory global strategy, review of design changes, manufacturing changes and specification changes.

You will work from our St Paul, Minnesota location support the regulatory department to ensure efficient and compliant business processes and environment. You will partner across business functions working on next generation Electrophysiology Medical Systems for navigation, mapping and ablation .

Job Duties:

  • Develop US and EU regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.

  • Assist in keeping company informed of regulatory requirements in the US and EU.

  • Participate on Product Development teams by providing regulatory strategy, timelines, and direction.

  • Prepare US and EU submissions. Work with Notified Body and FDA to obtain product approval/clearance. Ensure relevant ISO and FDA requirements are met, as required.

  • Review Change Orders and assess regulatory impact of product changes on US and/or EU regulatory strategy and submissions per standard procedures.

  • Review labeling, training, promotional and advertising material.

  • Support post market regulatory compliance activities for US/EU product approvals.

  • Develop and maintain regulatory affairs department procedures and process improvements

  • Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct

  • Assist in keeping company informed of regulatory requirements in the US and EU.

  • Other tasks, as assigned.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required Qualifications

  • 5+ years of US/EU medical device regulatory experience with Bachelor’s degree (2 years of quality experience in medical device or a Master’s degree in Regulatory Affairs may substitute for up to 2 years of experience)

  • Bachelor's Degree required. Engineering or Advanced degree desired.

  • Working knowledge of FDA and EU requirements

Preferred Qualifications

  • 510(k), PMA, and/or IDE submission experience

  • Previous software (SW) or medical electrical equipment (MEE) submission experience

  • Degree in Engineering, Science, or Regulatory Affairs

  • Strong communication skills

  • Strong technical writing skills

  • Regulatory Affairs Certification

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: _ www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

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.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

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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