Senior Regulatory Specialist

About this role

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 115,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION:

Working at Abbott  

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.   You’ll   also have access to:  

• Career development with an international company where you can grow the career you dream of  

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.  

• An excellent retirement savings plan with high employer contribution  

• Tuition reimbursement, the   Freedom 2 Save   student debt   program   and   FreeU   education benefit - an affordable and convenient path to getting a bachelor’s degree  

• A company recognized as   a great place   to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune  

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists  

Our mission is to help people with heart failure survive and thrive. At Abbott’s Heart Failure (HF) business, we pioneer and increase access to lifesaving, connected innovations that empower people to take control of their health by delivering seamless clinical solutions from diagnosis to   monitoring   and treatment.  

The Opportunity  

This   Senior Regulatory Affairs Specialist   will work out of o ur Pleas a nton , CA location in the   Heart Failure   Division. As an individual contributor   in   the function of a Sr. Regulatory Affairs Specialist, you will provide support to the Regulatory Affairs department .   With limited   supervision   you will execute tasks and partner across business functions.  

As an individual contributor, the Senior Regulatory Affairs Specialist will support product development and regulatory activities.    

What   You’ll   Work On     • As the Experienced professional in the Regulatory Affairs Sub-Function,   possesses   well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.   • Interacts with   FDA and other   regulatory agency to   expedite   approval of pending registration.   • Serves as   regulatory   liaison throughout product lifecycle.   •   Participates   in some of the following: product plan development and implementation, regulatory strategy, risk management,   • Ensures   timely   approval of   medical devices and continued approval of marketed products.  

• Interfaces directly with FDA and other regulatory agencies.  

• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.  

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

• Creates,   reviews   and approves engineering change orders.  

• Reviews protocols and reports to support regulatory submissions.  

• Supports all business segment initiatives as   identified   by divisional 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.   • Serves as regulatory representative to marketing, research   teams   and regulatory agencies.   • Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling,   appropriate regulations   and interpretations.  

Required Qualifications   

• Bachelors   Degree (± 16 years) Technical discipline highly   preferred   OR a n equivalent combination of   education and work experience  

• Minimum 5 years   Technical   experience, including at least 4 years of regulatory experience in a medical   d evice industry.  

• Experience with 510(k) applications, PMA   supplements   and US device regulations and/or    

• experience with EU and other international medical device regulations and submissions.  

• Experience working in a broader enterprise/cross-division business unit model preferred.  

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

• Ability to work within a team and as an individual contributor in a fast-paced, changing   environment.    

• Ability to   leverage   and/or engage others   to accomplish   projects.    

• Stron g verbal and written communication with   ability   to effectively communicate at multiple levels in the   organization .  

• Multitasks,   prioritizes   and meets deadlines in   timely   manner.    

• Strong   organization   and follow-up skills, as well as attention to detail.  

• Ability to travel approximately 5%, including   internationally.  

P referred Qualifications   

• Masters   Degree (± 18 years), In Regulatory Affairs preferred and may be used in lieu of direct regulatory   experience.Minimum   3 years, 3-4   years experience   in a regulated industry (e.g., medical products,   nutritionals ). 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related   area . Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society .)  

• Experience with review of labeling, promotional, and or advertising materials is highly

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