Regulatory Affairs Specialist II – Structural Heart (on-site)

Abbott • New Brighton, MN

1d • $61,300 - $122,700 • Onsite

About The Position

Abbott is recruiting a Regulatory Affairs Specialist II to join its Structural Heart team on-site in New Brighton, Minnesota. This individual-contributor role supports the regulatory department in maintaining efficient, compliant business processes and may assist with worldwide product registration by preparing and submitting regulatory documentation, with a strong focus on post-market change management. The role involves working within a fast-paced, matrixed environment and collaborating with cross-functional teams. The position also supports quality-system effectiveness and compliance, and may provide input on regulatory strategies and plans. Supervisory regulatory review is required before submission documents are sent to government agencies. The role requires travel approximately 5% of the time. Abbott’s Structural Heart business develops and provides devices and management solutions to treat structural heart disease.

Requirements

• Bachelor’s degree or an equivalent combination of education and work experience.
• 2–3 years of experience in a regulated industry, such as medical products or nutritionals; regulatory experience is preferred. Relevant experience in quality assurance, research and development/support, scientific affairs, operations, or a related area may be considered.
• Higher education may compensate for years of experience.
• Ability to work in a team and complete projects in a fast-paced, matrixed environment.
• Strong verbal and written communication skills, including the ability to communicate effectively at multiple organizational levels.
• Ability to exercise judgment within generally defined practices and policies when selecting methods and techniques to find solutions.
• Sound knowledge of alternatives and their impact on the business.
• Ability to apply business and regulatory ethical standards.

Nice To Haves

• Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, or pharmacology), mathematics, engineering, or a medical field.
• Regulatory Affairs Certification (RAC) or a similar certification.
• Analytical thinking and good problem-solving skills.

Responsibilities

• Analyze cumulative product changes and their impact on current product submissions.
• Share knowledge with colleagues and cross-functional teams.
• Analyze problems and provide solutions requiring a moderate degree of evaluation.
• Align individual goals with department goals, establish project goals, and implement plans.
• Provide input into group plans and their implementation.
• Follow GMP guidelines and procedures.
• Prepare clear, concise written information for varied audiences, particularly external regulatory agencies.
• Implement and maintain the effectiveness of the quality system.
• Advise and communicate basic regulatory strategies to projects, groups, or ventures for division-wide products.
• Sign off at the team level within delegated parameters for change control.
• Authorize release of labeling and sales or promotional materials.
• Conduct basic negotiations with government agencies on routine product-related issues.
• Follow through on submission-related activities to secure product approval.
• Direct daily activities in line with team goals and division regulatory priorities.
• Support Regulatory Affairs management in resolving compliance issues in accordance with site and division policies, procedures, and quality-system requirements.
• Obtain supervisory regulatory review of submission documents before submitting them to government agencies.
• Prepare and submit documentation needed for product registration worldwide, with a focus on post-market change management.

Benefits

• Potential eligibility for free medical coverage through the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit providing an affordable and convenient path to earning a bachelor’s degree.
• Career development opportunities with an international company.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level