Regulatory Affairs Specialist II – Electrophysiology (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.

In Abbott’s Electrophysiology (EP) business, we’re advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.

Abbott is seeking a passionate, experienced Regulatory Affairs Specialist II to join our team on-site in Plymouth, MN.  In this role, you will perform specialized level work assignments and/or analyses, evaluation, preparation and general support of global regulatory activities. This role requires strong attention to detail, technical competence, and effective communication skills to collaborate across multiple functional areas. Proven successful track record of authoring/submission/approval implantable medical devices is preferred.

• Authoring and submitting US PMA supplements (30-day Notice, Real-Time Reviews, 180-Day Supplements, Annual Reports), 510(k)s and EU change notifications.
• Review/approval of engineering study protocols/reports and validation study protocols/reports.
• Review and approval of manufacturing changes for Class III implantable medical devices.
• Support regulatory projects by processing quality documentation and performing regulatory assessments.
• Ensure integrity, accuracy, consistency, and completeness of assigned documentation and deliverables.
• Communicate with cross-functional teams including Program Management, Quality Engineering, R&D and Supply Chain regarding inquiries and documentation requirements in alignment with regulatory standards to ensure seamless execution of tasks.
• Participate in program strategy and contribute to process improvements.
• Complete additional projects as assigned by management while maintaining compliance with applicable regulations.
• Performs other related duties and responsibilities as assigned.

• Bachelor’s degree (or equivalent)
• 2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.  
• Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.

• Bachelor’s degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields. 
• Master’s degree in Regulatory Affairs.
• Strong attention to detail and ability to work independently as well as collaboratively within teams.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint), Adobe Acrobat, and SharePoint. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.)  

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