Regulatory Affairs Manager – Electrophysiology (On-site) | Abbott, Plymouth, MN
Job Summary
Abbott, a global healthcare leader, is hiring a Regulatory Affairs Manager – Electrophysiology for its Plymouth, Minnesota facility. This on-site role offers an opportunity to shape global regulatory strategies for cutting-edge electrophysiology devices. The ideal candidate will bring expertise in FDA 510(k) and PMA submissions, international regulatory frameworks, and cross-functional leadership in medical device regulatory compliance.
Key Responsibilities
Develop and implement new regulatory policies, processes, and SOPs.
Provide strategic regulatory input to product lifecycle planning and development teams.
Assist in multi-country regulatory strategy creation and updates based on evolving regulations.
Evaluate and mitigate regulatory risks associated with new products and acquisitions.
Compile, review, and submit regulatory documents to global authorities.
Assess the impact of regulatory changes on product strategies and communicate updates.
Guide preclinical, clinical, and manufacturing teams on regulatory documentation.
Oversee compliance with post-market approval requirements and reporting systems.
Manage regulatory response processes for audits, recalls, and adverse event reporting.
Lead and mentor regulatory affairs team members, providing technical guidance.
Interface with global regulatory bodies to secure product approvals and maintain licenses.
Required Skills & Qualifications
Bachelor’s degree in science, engineering, or related technical field (or equivalent).
4–5 years' experience in regulated industries (medical devices, nutritionals, or related).
2–5 years regulatory affairs experience preferred; may consider QA, R&D, scientific affairs.
Strong communication and negotiation skills with internal teams and regulatory agencies.
Detail-oriented with ability to manage complex regulatory information.
Ability to work cross-functionally and lead team efforts effectively.
Familiarity with FDA 510(k), PMA processes, and international regulations (EU MDR, etc.).
Preferred Skills & Qualifications
Master’s or PhD in a technical or regulatory field or MBA.
RAC certification or equivalent (Regulatory Affairs Professionals Society preferred).
Experience supervising and coaching regulatory teams.
Previous work with electrophysiology or medical device product lines.
Experience managing complex regulatory submissions and interacting with global authorities.
Perks & Benefits
Competitive Salary Range: $97,300 – $194,700 annually.
Comprehensive health, dental, vision coverage starting from day one.
Robust 401(k) retirement plan with generous company match.
Tuition reimbursement and educational assistance programs.
Paid vacation, holidays, and personal days.
Career growth in a globally recognized healthcare organization.
Company Description
Abbott is a global leader in healthcare innovation, delivering advanced diagnostics, medical devices, nutrition, and branded generic medicines. With over 114,000 employees worldwide, Abbott’s mission is to help people live fuller, healthier lives through breakthrough medical technologies.
Work Mode
On-site — Plymouth, Minnesota, United States.
Call to Action
Ready to drive regulatory strategy in a leading medical device company? Apply now and contribute to Abbott’s pioneering electrophysiology innovations.
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