Regulatory Affairs Specialist II - 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.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Structural Heart Business Mission: why we exist

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 are recruiting for a Regulatory Affairs Specialist II to join our team in our St. Paul/Lillehei, MN or Santa Clara, CA location. 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

• Assist in the development of multi-country regulatory strategy and update strategy based upon regulatory changes.
• Assist in assessing the acceptability of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities.
• Individuals execute and manage technical and scientific regulatory activities. Must function independently (with oversight) as a decision-maker on regulatory issues and must assure that deadlines are met.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required:

• Bachelor’s degree
• 2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
• Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

Preferred

• Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)
• Proficient with MS Office suite (Word, Excel, Outlook)

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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