Regulatory Affairs Specialist II

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 and Heart Failure division, we're advancing the treatment of heart and vascular disease through breakthrough medical technologies in electrophysiology and heart failure, allowing people to restore their health and get on with their lives.

Our location in Plymouth, MN, currently has an opportunity for a Regulatory Affairs Specialist II . In this role, you will be working on specialized level assignments and/or analyses, evaluation, preparation, and submissions for regulatory approval. This role ensures products and procedures comply with regulatory agency requirements. You will also be supporting all necessary regulatory activities required for product market entry and continuation.

WHAT YOU'LL DO

• Prepares robust international regulatory submissions to achieve departmental and organizational objectives.
• Supports project teams by providing review and analysis of applicable regulatory guidelines and project regulatory assessments as needed.
• Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards.
• Maintains current on pertinent domestic and international medical device regulations to ensure submission requirements are current, up-to-date and are entered into regulatory submission database and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• Collaborates with regulatory affairs peers to ensure successful world-wide regulatory assessments and submissions.
• Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
• Reviews protocols and reports to support regulatory submissions.
• Support all Company initiatives as identified by 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.
• Leads international regulatory projects, ensuring coordination between the regulatory team and impacted business functions.
• Manages multiple regulatory submission activities in parallel, and balances priorities to align with business objectives.
• Works with international regulatory colleagues to develop and implement effective regulatory strategies to support timely international approvals, aligned with business objectives.

EDUCATION AND EXPERIENCE YOU'LL BRING

Required

• Bachelor's Degree in a scientific or technical field or related discipline
• 2+ years of regulatory and/or general medical experience, including regulatory submission experience and/or technical writing/documentation experience
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization
• Worked in a highly matrixed and geographically diverse business environment
• Ability to identify and solve problems and work independently with little oversight

Preferred

• Master's Degree in Regulatory Affairs
• Medical device experience
• Previous experience supporting international regulatory affairs
• Prior experience working in a broader enterprise/cross-division business unit model

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:

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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