Regulatory Affairs Specialist Ii

3+ years

Not Disclosed

United States

10 Nov. 12, 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

Position Title:

Regulatory Affairs Specialist II – Medical Devices (On-site)

Location:

Pleasanton, California, USA

Department:

Regulatory Affairs

Company Overview:

Abbott is a global healthcare leader helping people live more fully at all stages of life. Its portfolio spans diagnostics, medical devices, nutritionals, and branded generic medicines, supported by 114,000 colleagues across 160+ countries.

Abbott’s Medical Devices Division develops advanced technologies across glucose monitoring, cardiac care, pain management, and movement disorder therapy—impacting over 10,000 patients daily and freeing over 500,000 diabetics from routine fingersticks.

Working at Abbott – What You’ll Get:

🌍 Career Growth: International career development opportunities with a global leader.
💰 Free Medical Coverage: Eligibility for the Health Investment Plan (HIP) PPO.
💼 Retirement & Savings: Excellent 401(k) plan with high employer contribution.
🎓 Education Benefits: Tuition reimbursement, Freedom 2 Save student debt program, and FreeU bachelor’s degree pathway.
🏆 Recognition:
- Named one of Fortune’s Most Admired Companies.
- Recognized among the Best Big Companies to Work For and top employers for diversity, women, and scientists.

The Opportunity:

Abbott is seeking a Regulatory Affairs Specialist II to join its Pleasanton, CA team.
This role supports global regulatory activities to ensure efficient, compliant business processes and successful worldwide registrations for Abbott’s medical devices.

You’ll collaborate across departments, help prepare global submissions, and ensure Abbott products meet regulatory requirements for market entry.

Key Responsibilities:

Regulatory Submissions & Documentation

Author, coordinate, compile, and submit international regulatory submissions, including:
- Technical Documentation
- Premarket Notifications (510k)
- Supplements and Change Notifications
- Product Registrations
Prepare robust regulatory applications aligned with departmental and corporate goals.
Represent Regulatory Affairs in cross-functional product development and manufacturing teams.

Regulatory Liaison & Communication

Serve as liaison with regulatory authorities and notified bodies, ensuring effective communication and complete submissions.
Interface directly with FDA and other international regulatory agencies as required.
Maintain productive relationships with external stakeholders, ensuring clarity and compliance.

Compliance & Surveillance

Maintain active surveillance of international medical device regulations, ensuring databases and systems reflect current requirements.
Communicate updates or regulatory changes to relevant internal personnel.
Review product and manufacturing changes for compliance with global standards.
Support and uphold Quality Management Systems (QMS) and Environmental Management Systems (EMS).

Cross-Functional Collaboration & Support

Collaborate with R&D, QA, and Operations teams to ensure regulatory readiness.
Support company initiatives aligned with quality, compliance, and regulatory improvement.
Maintain positive relationships across employees, contractors, and vendors.

Required Qualifications:

Bachelor’s degree in Science, Engineering, Math, or Medical fields (e.g., Biology, Chemistry, Microbiology, Pharmacy, Pharmacology, Immunology, Medical Technology).
2–3 years of experience in a regulated industry (e.g., medical devices, nutritionals, or pharmaceuticals).
- Regulatory Affairs preferred, but QA, R&D, or Operations experience acceptable.
Strong understanding (or developing knowledge) of:
- FDA and international regulatory frameworks
- GxPs (GCP, GLP, GMP)
- Product laws, submission types, and labeling/promotion requirements
Strong verbal and written communication skills; ability to interact effectively with diverse teams.
Strong organizational and analytical skills to manage complex regulatory information.
Proficiency in technical writing and documentation review.
Demonstrated ability to manage projects, create timelines, and meet deadlines.

Preferred Qualifications:

Master’s degree (preferred).
3+ years of regulatory submission experience in medical device or pharmaceutical industry.
Familiarity with U.S./EU medical device regulations, quality system standards, and clinical investigation requirements.
Experience with capital equipment and software-based devices a plus.
Proficiency with MS Office Suite (Word, Excel, Outlook).
Prior experience in matrixed, global organizations.
Strong negotiation, analytical, and decision-making skills.

Compensation & Benefits:

💵 Base Pay Range: $79,500 – $138,700 (may vary by location).
🏦 401(k) with Company Match: Generous employer contribution.
🏥 Comprehensive Health Benefits: Medical, dental, vision, and wellness programs.
🧘 Well-Being Support: Wellness initiatives and occupational health programs.
🌴 Paid Time Off (PTO): Competitive vacation and leave policies.
📚 Training & Career Growth: Onboarding, mentorship, and continuous learning programs.
🤝 Community Involvement: Strong corporate social responsibility and local engagement.

Application & Contact:

🔗 Apply Now: www.abbottbenefits.com
🌐 Company Website: www.abbott.com
📱 Connect:

Facebook: facebook.com/Abbott
Twitter: @AbbottNews

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Regulatory Affairs Specialist Ii

Job Description

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