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

Location: United States - California - Sylmar
Category: Regulatory Affairs

About Abbott

Abbott is a global healthcare leader committed to improving lives through innovative healthcare technologies. Our diverse portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines, serving over 160 countries with 114,000 employees worldwide.

Working at Abbott

At Abbott, you will have the opportunity to make a meaningful impact, grow professionally, and enjoy comprehensive benefits, including:

Career development opportunities with a global company.
Free medical coverage under the Health Investment Plan (HIP) PPO.
A competitive retirement savings plan with high employer contributions.
Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefits.
Recognition as a great workplace for diversity, working mothers, female executives, and scientists.

The Opportunity

Our Sylmar, CA location currently has an on-site opportunity for a Senior Regulatory Affairs Specialist within our Cardiac Rhythm Management division. This role involves preparing and submitting regulatory applications, acting independently to resolve challenges, and providing strategic regulatory guidance to cross-functional teams.

Responsibilities

Prepare and submit robust regulatory applications to achieve organizational goals.
Create, review, and approve change orders.
Serve as a regulatory representative on product development teams, ensuring compliance with applicable regulations.
Act as a liaison between Abbott and regulatory agencies, facilitating effective communication.
Maintain surveillance of domestic and international medical device regulations to ensure compliance.
Review product labeling and marketing materials for regulatory adherence.
Interface directly with FDA and other regulatory agencies.
Support product release processes and regulatory compliance for manufacturing changes.
Conduct reviews of protocols and reports for regulatory submissions.
Ensure compliance with U.S. FDA and international regulations, as well as Abbott policies and procedures.
Mentor and provide leadership to Regulatory Specialist I and II team members.

Required Qualifications

Bachelor's degree or an equivalent combination of education and experience.
Minimum 3 years of experience in a regulated industry (medical products, drug-device combination products, nutritionals).
2-3 years of experience in regulatory affairs preferred (quality assurance, R&D, scientific affairs, or operations may also be considered).
Knowledge of submission/registration types and requirements.
Strong verbal and written communication skills.
Ability to multitask, prioritize, and meet deadlines.
Strong organizational and follow-up skills with keen attention to detail.

Preferred Qualifications

Master’s degree in Regulatory Affairs (may substitute for direct regulatory experience).
Experience with 510(k) applications, PMA supplements, IDE, and US device regulations, as well as EU and other international medical device regulations.
Knowledge of electronic submission formats such as eCTD and NeeS.
Certification (e.g., RAC from the Regulatory Affairs Professionals Society) is a plus.
Experience working in a matrixed and geographically diverse business environment.
Ability to work independently and collaboratively in a fast-paced setting.
Strong leadership and project management skills.

Compensation & Benefits

Base Pay: $86,700.00 – $173,300.00 (may vary by location).
Learn more about our health and wellness benefits: www.abbottbenefits.com.

Apply Now

Join Abbott for a career where you can make a difference, grow, and thrive. We are an Equal Opportunity Employer committed to diversity and inclusion.

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

Job Description

About Abbott

Working at Abbott

The Opportunity

Responsibilities

Required Qualifications

Preferred Qualifications

Compensation & Benefits

Apply Now

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