Regulatory Affairs Specialist Ii

2-3 years

$79,500 – $138,700

California United States

10 Dec. 15, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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 – Medical Devices

Location: Pleasanton, California, United States
Employment Type: Full-Time, On-Site
Category: Regulatory Affairs
Experience Required: 2–3 years in a regulated industry (medical devices, pharmaceuticals, or nutritionals)

About Abbott

Abbott is a leading global healthcare company dedicated to helping people live healthier, fuller lives. Our diverse portfolio spans diagnostics, medical devices, nutritionals, and branded generics, impacting millions of patients worldwide. With over 114,000 colleagues across 160+ countries, Abbott is committed to innovation, quality, and patient-centric solutions.

Abbott’s medical device technologies—from advanced glucose monitoring systems to heart disease therapies—enhance patient health, quality of life, and independence. Each day, our technologies help over 10,000 patients improve cardiac health, manage chronic pain, and transform diabetes management.

Role Overview

Abbott is seeking a Regulatory Affairs Specialist II to join the team in Pleasanton, CA. This role provides regulatory support to ensure compliance across global business processes. The Specialist II will collaborate across business functions, assisting in the collection of necessary data, preparing regulatory submissions, and ensuring worldwide product registration requirements are met efficiently and accurately.

Key Responsibilities

Prepare, compile, and submit international regulatory submissions, including technical documentation, premarket notifications, supplements, change notifications, and other product registrations.
Support the preparation of robust regulatory applications to achieve departmental and organizational objectives.
Serve as a regulatory liaison within cross-functional product development and manufacturing teams.
Interface with regulatory authorities to ensure clear, complete, and accurate communication.
Maintain ongoing surveillance of global medical device regulations, ensuring compliance with current submission requirements.
Review product and manufacturing changes for regulatory compliance and provide guidance accordingly.
Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory initiatives.
Ensure all regulatory activities comply with company policies, international regulations, and applicable guidelines.
Collaborate with external partners, regulatory agencies, and notified bodies as required.

Required Qualifications

Bachelor’s degree in a scientific, technical, or medical discipline (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, engineering, math).
Minimum 2 years of experience in a regulated industry. Regulatory affairs experience is preferred, but related fields such as quality assurance, R&D, scientific affairs, operations, or regulatory support are acceptable.
Strong verbal and written communication skills with ability to effectively communicate across functions and cultures.
Demonstrated analytical and critical thinking, attention to detail, and project management skills.
Ability to manage multiple priorities, create project plans, and organize complex information.
Knowledge of regulatory submission types, principles, guidelines, and agency processes, including GxPs, labeling, and advertising regulations.

Preferred Qualifications

3+ years of regulatory submission experience in medical devices or pharmaceuticals.
Master’s degree or advanced degree in a related field.
Familiarity with US and EU regulatory requirements for medical devices, including Quality Systems standards and clinical investigations.
Experience working in a matrixed, geographically diverse organization.
Proficiency with Microsoft Office suite (Word, Excel, Outlook).

Benefits & Career Growth

At Abbott, you can build a career that grows with you. Benefits include:

Training, onboarding programs, and tuition assistance for career development.
Competitive compensation, performance incentives, and retirement plans.
Comprehensive healthcare programs including medical, dental, vision, wellness, and occupational health.
Paid time off and 401(k) retirement savings with generous company match.
Stability and growth with a company recognized for financial strength, innovation, and community involvement.

Learn more about Abbott’s benefits: www.abbottbenefits.com

Why Abbott

Abbott offers opportunities for regulatory professionals to contribute globally, expand expertise, and impact patient care worldwide. We are an Equal Opportunity Employer, committed to employee diversity and inclusion.

Apply Now to advance your career in regulatory affairs with Abbott.

Base Salary: $79,500 – $138,700 (location-dependent)

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Regulatory Affairs Specialist Ii

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