Senior Specialist Regulatory Affairs - Structural Heart

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.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

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.

We are recruiting for a Senior Regulatory Affairs Specialist to join our team in our Santa Clara, CA or St. Paul, MN locations. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You will provide regulatory guidance to cross-functional partners in support of various programs.

WHAT YOU’LL DO

• Prepares robust regulatory applications to achieve departmental and organizational objectives.
• Creates, reviews and approves engineering change orders.
• Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team. Provides guidance and expertise.
• Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail.
• Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• Reviews device labeling and marketing materials for compliance with FDA submissions and applicable regulations.
• 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.
• 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.
• Provides mentoring and leadership to other Regulatory team members

EDUCATION AND EXPERIENCE YOU’LL BRING

Required:

• Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc.
• Minimum 2 yrs. regulatory experience and or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function.

Preferred

• 4+ years of related regulatory submission experience from medical device, pharmaceutical, or healthcare industry
• Advanced level degree
• Class II or Class III medical device experience
• Experience with 510(k) applications, PMA supplements and US device regulations and/or experience with EU and other international medical device regulations and submissions.
• Proficient with MS Office suite (Word, Excel, Outlook)
• Previous experience working in a highly matrixed and geographically diverse business environment
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

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. Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

• 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

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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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