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

Abbott • Saint Paul, MN

6d • Onsite

About The Position

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 115,000 colleagues serve people in more than 160 countries. Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of Employees can qualify for 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 - an affordable and convenient path to getting a bachelor’s degree A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists Structural Heart Business Mission: why we exist Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. The Opportunity We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in New Brighton, MN. This new team member will be overseeing our innovating Transcatheter Aortic Valve Implantation Franchise within the Abbott Structural Heart Franchise. As an individual contributor, the Senior Regulatory Affairs Specialist will support product development activities to ensure both investigation and commercial regulatory approvals are achieved. In this role, you will provide regulatory input on design and development activities to cross functional teams including software development. Additionally, provide submission authoring and compilation 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
• Strategic Planning: Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
• Premarket: 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.
• Postmarket: 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

• Employees can qualify for 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 - an affordable and convenient path to getting a bachelor’s degree

What This Job Offers

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