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.

Regulatory Affairs Specialist II – Pleasanton, CA 

ABOUT ABBOTT

Leading an active lifestyle is important to the many people we serve. In Abbott’s ELECTROPHYSIOLOGY & HEART FAILURE division, we’re advancing the treatment of heart and vascular disease through breakthrough medical technologies in EP/HF, allowing people to restore their health and get on with their lives. 

WHAT YOU’LL DO 

We are recruiting for a Regulatory Affairs Specialist I to join our team in the St. Paul, MN location.  In this role, you will be responsible for obtaining and maintaining product release authorization and release of product to specified geographies. Coordinating with cross functional teams including but not limited to: International Regulatory, Marketing / PLC, Supply Planning, Customer Service, etc. to ensure all internal and external requirements are met prior to product release.

Responsibilities:

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

• Provides support to the Regulatory team and is responsible for validating the Global Product Registration (GPR) Library approval record metadata.

• Assists with the development of processes and tools to support controlled product release.

• Analyzes product release-associated issues and develop proposals for solutions.

• Supports Product Release Planning

• Responsible for maintenance of applicable department standard operating procedures and work instructions.

• 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.

• Other duties as assigned.

EDUCATION AND EXPERIENCE, YOU’LL BRING 

Required 

• Bachelor’s degree

• 3+ years of experience in a similar role from a medical device or from regulated industry (i.e. aerospace, pharmaceutical, etc.)

• Proficient in Microsoft Word, Excel, and PowerPoint

• 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 

• Advanced level degree in an Engineering or Scientific discipline

• Demonstrated experience working with technical documentation

• Experience with 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:  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