Principal Regulatory Affairs Specialist Electrophysiology (on-site)

Principal Regulatory Affairs Specialist

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 114,000 colleagues serve people in more than 160 countries.

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.

The Opportunity

We are seeking a Principal Regulatory Affairs Specialist to join Abbott's Electrophysiology Division on-site in Plymouth, MN or St. Paul, MN. As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. This position performs specialized level work assignments and / or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications. Supports necessary regulatory activities required for product market entry.

The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these 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.

What You'll Work On

• Develops worldwide strategies for regulatory approval of new and modified products.
• Prepares robust regulatory applications for FDA and / or international regulatory agencies to achieve departmental and organizational objectives. Coordinates, compiles, and submits regulatory submissions, including IDE, European Dossiers, Premarket Notifications, PMA Supplements, Change Notifications, and other country-specific product registrations.
• Represents Regulatory Affairs on cross-functional product development and manufacturing support teams. Guides teams to provide content for submissions and participates in design reviews as needed.
• Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements.
• Subject Matter Expert (SME) for audits and inspections by internal teams or external regulatory authorities.
• Acts as liaison between the Company and in-country affiliates as well as the various regulatory agencies, ensuring that communications are relevant, specific and convey all necessary detail.
• Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements worldwide are current, up-to-date and are entered into the regulatory submission database and file systems.
• Supports the product implementation process by creating database (GTS) licenses or reviewing and approving requests for product release.
• Interfaces directly with regulatory agencies as needed.
• Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
• Communicates with and maintains productive, constructive relationships with external customers as required regulatory authorities, Notified Bodies, in-country affiliates and / or distributors.
• Support Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Helps to mentor regulatory affairs specialists and share knowledge and expertise with others in support of team activities.
• Complies with US Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Performs other related duties and responsibilities, on occasion, as assigned.

Required Qualifications

Preferred Qualifications

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives.

Connect with us at Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.