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

Abbott • New Brighton, MN

7d • $78,000 - $156,000 • Onsite

About The Position

This role is for a Senior Regulatory Affairs Specialist on-site in New Brighton, MN, focusing on the Transcatheter Aortic Valve Implantation Franchise within the Abbott Structural Heart Franchise. As an individual contributor, the specialist will support product development to achieve investigation and commercial regulatory approvals. Responsibilities include providing regulatory input to cross-functional teams, including software development, and authoring and compiling submissions to meet program objectives and timelines.

Requirements

• Bachelor’s Degree or an equivalent combination of education and experience
• 3-4 years’ experience in a regulated industry (e.g., medical products, nutritionals).
• 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area.
• Effectively communicate, prepare, and negotiate both internally and externally with various regulatory agencies.
• Communicate effectively verbally and in writing.
• Ability to work in a highly matrixed and geographically diverse environment.
• Has broad knowledge of various technical alternatives and their potential impact on the business.
• Exercise good and ethical judgment within policy and regulations.
• Use in-depth knowledge of business functions and cross group dependencies/ relationships.
• Define regulatory strategy with supervision.
• Follow scientific arguments, identify regulatory scientific data needs and with supervision solve regulatory issues.

Nice To Haves

• Master’s Degree in Regulatory Affairs preferred and may be used in lieu of direct regulatory experience.
• 5+ years’ experience in Medical Device industry
• 3 - 5 years of regulatory experience.
• Knowledge of software and electrical regulations.
• Ability to think analytically and have good problem-solving skills.
• PMA or investigational device regulatory submission experience.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)

Responsibilities

• Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for Class III medical devices which may include software.
• Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
• Assess the acceptability of quality, preclinical and clinical documentation for submission filing.
• Compile, prepare, review and submit regulatory submission to authorities to support both investigational and commercial approval.
• Utilize technical regulatory skills to propose strategies on complex issues.
• Monitor impact of changing regulations on submission strategies.
• Monitor applications under regulatory review.
• Monitor and submit applicable reports to regulatory authorities.
• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval.
• Maintain annual licenses, registrations, listings and patent information.
• Assist compliance with product postmarketing approval requirements.
• Submit and review change controls to determine the level of change and consequent submission requirements.
• Analyze the input of cumulative product changes to current product submissions.

Benefits

• Free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit
• Health and wellness benefits

What This Job Offers

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