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

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

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.

We are recruiting for a Senior Regulatory Affairs Specialist to join our team on-site in New Brighton, MN. This new team member will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions as well as assist in identifying data needed, obtaining this data and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation, with a primary focus on post-market change management.

• Assist in SOP development and review. Provide regulatory input to product lifecycle planning. Continue to revisit and compare regulatory outcomes with initial product concepts to make recommendations on future actions. Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
• Understand, investigate and evaluate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval. Determine trade issues to anticipate regulatory obstacles. Determine and communicate submission and approval requirements. Participate in risk-benefit analysis for regulatory compliance.
• 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. Obtain US and EU post-market change approvals/clearances while coordinating necessary submissions and approvals with international affiliates to maintain compliance with product postmarketing approval requirements.
• Strong technical writing for regulatory agency audience, able to independently draft US and EU post-market change submissions and deficiency responses.
• 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.
• Contribute to the development and functioning of the crisis/ 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 Job specific responsibilities may include (choose applicable areas and expand as appropriate).
• Medical writing, Advertising and promotion, Labeling, Controlled substances (e.g. DEA), Restricted substances (e.g. REACH), Compendial / standards, Import / export, Country specific regulatory support, including animal tissue documentation.

• 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.

• 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.
• Think analytically with good problem-solving skills.
• 510(k), PMA, or other international regulatory submission experience.
• Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).

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