ABBOTT LABORATORIES Regulatory Affairs Specialist II Salary in the United States

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.

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

Regulatory Affairs Specialist II

WHAT YOU’LL DO 

As Regulatory Affairs Specialist II, you will 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.

As Regulatory Affairs Specialist II, you will work from our St Paul location support the regulatory department to ensure efficient and compliant business processes and environment.  You will partner across business functions with regard to next generation Electrophysiology Medical Systems for navigation, mapping and ablation, which includes a combination of Hardware, software, and accessories. 

WHAT YOU’LL DO 

• 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.

• Provide regulatory input to product lifecycle planning. Assist in SOP development and review.

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

EDUCATION AND EXPERIENCE YOU’LL BRING 

REQUIRED

• Bachelor's Degree required.  Engineering or science major preferred.

• 2 years of medical device experience with Bachelor’s degree (Master’s degree may substitute for some experience)

• Knowledge of FDA and EU requirements

• Ability to schedule and organize multiple projects

• Ability to communicate effectively with internal and external customers and team members.

PREFERRED 

• 510(k) or PMA submission experience

• Degree in Engineering, Science, or Regulatory Affairs

• Advanced degree

• Strong communication skills

• Strong technical writing skills

• Regulatory Affairs Certification

• Master’s degree in Regulatory Affairs or Engineering

• PMA experience

• IDE experience

• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

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  

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.