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

Abbott • Saint Paul, MN

12d • Onsite

About The Position

Abbott is seeking 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. The specialist partners with teams across the business, identifies and obtains information needed for product registration worldwide, and prepares or oversees registration documentation, with a primary focus on post-market change management.

The specialist contributes to regulatory strategy and product lifecycle planning, supports regulatory submissions and interactions with authorities, and assesses how product, manufacturing, clinical, preclinical, and regulatory changes affect filing requirements. The position also supports post-market compliance, product safety reporting, issue management, and recalls.

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.
• Ability to communicate, prepare, and negotiate effectively with internal and external parties, including 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.
• Good and ethical judgment in accordance with policies and regulations.
• In-depth knowledge of business functions and cross-group dependencies and relationships.
• Ability to define regulatory strategy with supervision.
• Ability to understand scientific arguments, identify regulatory scientific data needs, and resolve regulatory issues with supervision.

Nice To Haves

• 2–3 years of regulatory experience; candidates with experience in quality assurance, research and development/support, scientific affairs, operations, or a related area may also be considered.
• Master’s degree in Regulatory Affairs, which may be considered in lieu of direct regulatory experience.
• 5 or more 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 Affairs Certification (RAC) or similar certification.

Responsibilities

• Assist in developing and reviewing standard operating procedures.
• Provide regulatory input to product lifecycle planning and compare regulatory outcomes with initial product concepts to recommend future actions.
• Assist in developing regional regulatory strategies and update strategies in response to regulatory changes.
• Research and evaluate regulatory history and the disease, therapeutic, or diagnostic context to assess approval implications.
• Identify trade issues and potential regulatory obstacles.
• Determine and communicate submission and approval requirements.
• Participate in regulatory compliance risk-benefit analyses.
• Monitor regulatory changes and their impact on submission strategies, as well as applications under regulatory review.
• Monitor and submit applicable reports to regulatory authorities.
• Evaluate proposed preclinical, clinical, and manufacturing changes to determine 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 US and EU post-market change approvals or clearances and coordinate related submissions and approvals with international affiliates.
• Independently draft US and EU post-market change submissions and deficiency responses.
• Submit and review change controls, determine change levels and resulting submission requirements, and analyze cumulative product changes against current submissions.
• Contribute to the development and operation of the crisis and issue management program.
• Ensure product safety issues and product-associated events are reported to regulatory agencies.
• Provide regulatory input for product recalls and recall communications.
• Provide support in applicable areas such as medical writing, advertising and promotion, labeling, controlled or restricted substances, compendial standards, import/export, country-specific regulatory support, and animal tissue documentation.

Benefits

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

What This Job Offers

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