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Regulatory Affairs Manager - Electrophysiology (On-Site)

4-5 years
$97,300 – $194,700
10 July 28, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

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.