Regulatory Affairs Specialist Ii – Electrophysiology (On-Site)

3+ years

$60,000.00 – $120,000.00

Plymouth Meeting

10 March 10, 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 Specialist II – Electrophysiology (On-Site)

Location: United States - Minnesota - Plymouth
Category: Regulatory Affairs

About Abbott:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines. With 114,000 colleagues across more than 160 countries, Abbott is committed to innovation and excellence.

Working at Abbott:

At Abbott, you’ll have the opportunity to:

Grow your career with an international company.
Qualify for free medical coverage through our Health Investment Plan (HIP) PPO.
Benefit from an excellent retirement savings plan with high employer contributions.
Take advantage of tuition reimbursement and student debt assistance.
Work for a company recognized globally for workplace excellence and diversity.

Abbott’s Electrophysiology (EP) business advances heart disease treatment through breakthrough medical technologies in atrial fibrillation, helping people restore their health.

The Opportunity:

This individual contributor role involves performing specialized assignments, analyzing, evaluating, preparing, and submitting documentation for worldwide regulatory registration to ensure compliance with regulatory agency specifications. The role supports regulatory activities necessary for product market entry.

Responsibilities:

Prepare robust regulatory applications (FDA or international) to meet company objectives.
Create, review, and approve engineering changes.
Serve as a core team member, reviewing and analyzing regulatory guidelines.
Ensure regulatory communications are detailed and compliant with FDA and other agencies.
Maintain domestic and international medical device regulations and ensure up-to-date submissions.
Interface with FDA and other regulatory agencies as required.
Support product release processes by managing GTS licenses and approvals.
Review protocols and reports to support regulatory submissions.
Ensure compliance with FDA, international regulations, company policies, and QMS/EMS requirements.
Maintain positive collaboration with employees, customers, contractors, and vendors.

Required Qualifications:

Bachelor’s Degree or equivalent education/work experience.
Minimum 3 years of related experience, with at least 2 years in regulatory affairs.
Experience with 510(k) applications, PMA supplements, US device regulations, or international medical device regulations.
Ability to work in a matrixed and geographically diverse environment.
Strong verbal and written communication skills across multiple levels of an organization.
Strong organizational, follow-up, and multitasking skills.
Ability to prioritize tasks and meet deadlines.

Preferred Qualifications:

Bachelor’s Degree in Science/Technical discipline (engineering, life sciences, mathematics).
Master’s degree.
Experience in a cross-division business model.
Experience in the Medical Device industry.
Regulatory Affairs Professionals Society (RAPS) Certification is a plus.

Compensation:

Base Pay: $60,000 – $120,000 (may vary based on location).

Apply Now:

Learn more about our health and wellness benefits at www.abbottbenefits.com.

Abbott is an Equal Opportunity Employer committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews and @AbbottGlobal.

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Regulatory Affairs Specialist Ii – Electrophysiology (On-Site)

Job Description

About Abbott:

Working at Abbott:

The Opportunity:

Responsibilities:

Required Qualifications:

Preferred Qualifications:

Compensation:

Apply Now:

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