Senior Regulatory Affairs Specialist2 – Cardiac Rhythm Management (On-Site)

3+ years

$86,700.00 – $173,300.00

Sylmar

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

Senior Regulatory Affairs Specialist II – Cardiac Rhythm Management (On-Site)

Location: United States - California - Sylmar
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 in more than 160 countries, Abbott is committed to innovation and excellence.

Working at Abbott:

At Abbott, you will:

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.
Access tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefits.
Work for a company recognized globally for workplace excellence and diversity.

As a global leader in Cardiac Rhythm Technologies, Abbott focuses on innovative solutions that enhance the treatment of heart arrhythmias and irregular heartbeats.

The Opportunity:

Abbott’s Cardiac Rhythm Management division in Sylmar, CA has an on-site opportunity for a Senior Regulatory Affairs Specialist. This position leads the preparation and submission of regulatory approvals, acts independently to identify and resolve problems, and provides regulatory guidance to cross-functional partners. This role requires strategic thinking and creativity to support regulatory programs.

Responsibilities:

Prepare regulatory applications to achieve departmental and organizational objectives.
Create, review, and approve change orders.
Serve as a regulatory representative on core product development teams, communicating regulatory requirements and their impact.
Act as a liaison between Abbott and regulatory agencies, ensuring effective communication.
Maintain ongoing surveillance and analysis of global medical device regulations to ensure compliance.
Review device labeling and marketing materials for regulatory compliance.
Interface directly with FDA and other regulatory agencies.
Support the product release process by managing GTS licenses and approvals.
Conduct product and manufacturing change reviews for regulatory compliance.
Review protocols and reports to support regulatory submissions.
Ensure compliance with FDA, international regulations, and company policies.
Maintain collaborative communications with employees, customers, contractors, and vendors.
Provide mentorship and leadership to Regulatory Specialist I and II team members.

Required Qualifications:

Bachelor's degree or an equivalent combination of education and work experience.
Minimum 3 years of experience in a regulated industry (e.g., medical devices, nutritionals).
2-3 years of regulatory experience preferred (may consider quality assurance, R&D, scientific affairs, or related fields).
Experience with submission/registration types and requirements.
Strong verbal and written communication skills for multiple levels of an organization.
Ability to multitask, prioritize, and meet deadlines.
Strong organizational and follow-up skills with attention to detail.

Preferred Qualifications:

Master’s degree in Regulatory Affairs (may substitute for direct regulatory experience).
Experience with 510(k) applications, PMA supplements, and US device regulations or EU and other international medical device regulations.
Ability to work in a matrixed and diverse business environment.
Experience in the Medical Device industry.
Regulatory Affairs Certification (RAC) is a plus.

Compensation:

Base Pay: $86,700 – $173,300 (may vary by location).

Apply Now:

Learn more about Abbott’s 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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