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

Abbott Laboratories • New Brighton, MN

8d • $78,000 - $156,000 • Onsite

About The Position

Abbott is recruiting a Senior Regulatory Affairs Specialist to join its Structural Heart team on-site in New Brighton, Minnesota. The role supports the regulatory department in maintaining efficient, compliant business processes and may involve executing regulatory tasks or providing consultative support across business functions. The specialist helps identify and obtain data and ensure it is effectively presented for worldwide product registration. The position may prepare or oversee registration documentation, with a primary focus on post-market change management.

The Structural Heart business aims to restore health and improve quality of life through the design and provision of devices and management solutions for structural heart disease. This position supports product lifecycle planning and regulatory strategy, evaluates regulatory implications and requirements, and coordinates submissions, approvals, and ongoing compliance in the United States, Europe, and international markets.

Requirements

• Bachelor’s degree or an equivalent combination of education and experience.
• 3–4 years of experience in a regulated industry, such as medical products or nutritionals.
• 2–3 years of regulatory experience; experience in quality assurance, research and development/support, scientific affairs, operations, or a related area may also be considered.
• Ability to communicate effectively, prepare materials, and negotiate internally and externally with regulatory agencies.
• Effective verbal and written communication skills.
• Ability to work in a highly matrixed and geographically diverse environment.
• Broad knowledge of technical alternatives and their potential business impact.
• Sound, ethical judgment within applicable policies and regulations.
• In-depth understanding of business functions and cross-group dependencies and relationships.
• Ability to define regulatory strategy with supervision.
• Ability to follow scientific arguments, identify regulatory scientific data needs, and solve regulatory issues with supervision.

Nice To Haves

• Master’s degree in Regulatory Affairs, which may be considered in lieu of direct regulatory experience.
• 5+ years of experience in the medical device industry.
• 3–5 years of regulatory experience.
• Analytical thinking and good problem-solving skills.
• Experience with 510(k), PMA, or other international regulatory submissions.
• Regulatory certification, such as RAC from the Regulatory Affairs Professionals Society.

Responsibilities

• Assist with developing and reviewing standard operating procedures and provide regulatory input to product lifecycle planning.
• Compare regulatory outcomes with initial product concepts and recommend future actions.
• Assist in developing regional regulatory strategies and update them in response to regulatory changes.
• Investigate regulatory histories and relevant disease, therapeutic, or diagnostic contexts to assess approval implications and anticipate regulatory obstacles.
• Determine and communicate submission and approval requirements, and participate in regulatory compliance risk-benefit analyses.
• Monitor regulatory changes and their impact on submission strategies, applications under review, and applicable reports to regulatory authorities.
• Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing strategies.
• Interact and negotiate with regulatory authorities during product development and review to support submission approval.
• Maintain annual licenses, registrations, listings, and patent information.
• Obtain U.S. and EU post-market change approvals or clearances and coordinate submissions and approvals with international affiliates.
• Independently draft U.S. and EU post-market change submissions and deficiency responses.
• Submit and review change controls, determine change levels and submission requirements, and analyze cumulative product changes against current submissions.
• Contribute to crisis and issue management programs; ensure product safety issues and associated events are reported to regulatory agencies; and provide regulatory input for recalls and recall communications.
• Provide regulatory support in applicable areas such as medical writing, advertising and promotion, labeling, controlled or restricted substances, compendial standards, import/export, country-specific requirements, and animal tissue documentation.

Benefits

• Employees may qualify for free medical coverage in 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.

What This Job Offers

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