Regulatory Affairs Specialist – Electrophysiology (on-site)

Abbott is seeking a detail-driven Regulatory Affairs Specialist - Electrophysiology to join our on-site team in the United States, supporting the compliant development and global market access of advanced cardiac rhythm management technologies.

About the Role

As a Regulatory Affairs Specialist - Electrophysiology at Abbott, you will serve as a key liaison between product development teams and health authorities, ensuring that our electrophysiology medical devices meet evolving regulatory standards. This full-time, on-site position based in the US offers the chance to shape submissions and strategies for life-changing cardiac care products.

Key Responsibilities

• Prepare, compile, and submit regulatory documentation for electrophysiology devices to domestic and international health authorities.
• Develop regulatory strategies that support timely product approvals and sustained market access.
• Review labeling, technical files, and promotional materials to confirm alignment with applicable regulations.
• Partner with R&D, quality, clinical, and manufacturing teams to assess the regulatory impact of design and process changes.
• Monitor shifting regulatory requirements and translate them into clear, actionable guidance for the business.
• Support audits, inspections, and post-market compliance activities for cardiac electrophysiology product lines.

Qualifications

• Background in regulatory affairs, life sciences, engineering, or a related field relevant to medical devices.
• Working knowledge of regulatory frameworks governing electrophysiology or cardiovascular medical devices.
• Strong written and verbal communication skills for drafting submissions and engaging health authorities.
• Meticulous attention to detail, with the ability to manage multiple submissions and deadlines simultaneously.
• Collaborative mindset suited to cross-functional work in an on-site environment in the US.

About Abbott

Abbott is a global healthcare leader dedicated to helping people live fuller lives at every stage. Our wide-ranging portfolio of breakthrough technologies covers diagnostics, medical devices, nutrition, and branded generic medicines. With approximately 115,000 colleagues, we serve people across more than 160 countries, delivering innovations that make a meaningful difference in patients' lives.

How to Apply

To apply, complete your application directly on this page, or you'll be redirected to the employer's application platform to finish submitting there.