Regulatory Affairs Manager – Electrophysiology (On-site, MN)
Location: Plymouth, Minnesota
Salary Range: $97,300 – $194,700
Work Mode: On-site
Job Summary:
Abbott is hiring a Regulatory Affairs Manager to join its Electrophysiology division based in Plymouth, Minnesota. This full-time, on-site position requires 4–5+ years of regulatory experience in a highly regulated industry, preferably medical devices. You’ll oversee the development and execution of regulatory strategies for global submissions (including 510(k) and PMA), support product lifecycle planning, and lead regulatory teams for cardiovascular and electrophysiology products. This role offers strong leadership opportunities in a top-ranked healthcare organization and provides excellent benefits and career advancement.
Key Responsibilities:
Lead and develop regulatory teams to manage global submissions and compliance
Evaluate regulatory risks and develop mitigation strategies
Oversee and contribute to 510(k) and PMA submissions
Engage regulatory agencies throughout the submission and review process
Ensure compliance with post-market regulatory requirements
Collaborate with cross-functional teams and guide regulatory planning
Provide guidance on advertising and promotional review
Support due diligence efforts for mergers and acquisitions
Stay current with global regulatory changes and their business impact
Represent regulatory affairs in high-level internal and external forums
Required Skills & Qualifications:
Bachelor’s degree (preferably in science, engineering, or related field)
4–5 years in a regulated industry; 2+ years in regulatory affairs preferred
Strong knowledge of US FDA regulations, 510(k), PMA processes
Excellent verbal and written communication skills
Proven leadership in cross-functional team environments
Strong organizational and analytical skills
RAC certification (preferred)
Experience with medical devices or in a healthcare setting
Perks & Benefits:
Competitive salary ($97,300 – $194,700 depending on location/experience)
Career growth in a Fortune-recognized global healthcare company
Free medical coverage under HIP PPO plan (for qualifying employees)
High employer-contribution retirement savings plan
Tuition reimbursement and student debt assistance (Freedom 2 Save program)
FreeU education benefits for pursuing a bachelor’s degree
Inclusive work environment with recognition for diversity and innovation
Company Overview:
Abbott is a global leader in healthcare innovation, serving patients in over 160 countries. Its diverse portfolio spans diagnostics, nutritionals, medical devices, and branded generics. In the Electrophysiology division, Abbott develops life-saving technologies to treat cardiac rhythm disorders and improve cardiovascular health.
Work Mode:
On-site (Plymouth, Minnesota)
Call to Action:
Are you ready to lead regulatory affairs in a world-class medical device organization? Apply today and shape the future of electrophysiology care with Abbott.
Visit Abbott Careers or click Apply Now to start your application.
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