Regulatory Affairs Manager – Canada & Latin America

8 years

$112,000.00 – $224,000.00.

California

10 Sept. 9, 2025

Job Description

Job Type: Full Time Education: B.Sc/ M.Sc/ M.Pharm/ B.Pharm/ 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 Manager – Diabetes Care Division

Location: On-site, Alameda, CA
Company: Abbott

About Abbott

Abbott is a global healthcare leader dedicated to helping 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 serving people in more than 160 countries, Abbott continues to drive innovation in healthcare.

We are especially committed to transforming diabetes care. Our cutting-edge sensing technology is revolutionizing glucose monitoring, enabling people with diabetes to make better-informed decisions and live active lives.

Why Work at Abbott?

At Abbott, you’ll have the opportunity to:

Do meaningful work that impacts lives globally.
Grow and develop your career within an international company.
Access comprehensive health and wellness benefits, including HIP PPO medical plan, retirement savings with high employer contribution, and tuition reimbursement.
Benefit from programs like Freedom 2 Save (student debt assistance) and FreeU (affordable paths to a bachelor’s degree).
Work at a company recognized globally as one of the best places to work, with distinctions for diversity, working mothers, female executives, and scientists.

Learn more: www.abbottbenefits.com

The Opportunity

We are seeking a Regulatory Affairs Manager for our Diabetes Care Division in Alameda, CA. This role combines scientific, legal, and business expertise to ensure Abbott products meet Canadian and Latin American regulatory requirements.

The Regulatory Affairs Manager will:

Lead regulatory submissions and manage agency interactions.
Collaborate with in-country affiliates.
Analyze regulatory changes and implement strategies.
Manage and coach a team of regulatory professionals.

Key Responsibilities

Regulatory Strategy & Submissions

Develop and implement regulatory strategies for Canada and Latin America.
Provide regulatory input to product lifecycle planning and early product concepts.
Assess regulatory impact of design and manufacturing changes.
Compile, review, and submit regulatory documentation (licenses, registrations, filings).
Negotiate with regulatory agencies to obtain approvals.
Anticipate regulatory challenges and develop proactive solutions.

Team Leadership

Recruit, develop, and manage a team of regulatory professionals.
Set department-aligned goals and monitor progress through coaching and mentoring.
Provide training on new regulatory policies, SOPs, and processes.

Compliance & Risk Management

Evaluate regulatory risks of division processes and implement solutions.
Monitor trade association positions for impact on company products.
Ensure compliance with QSR, ISO, and EN standards.
Support internal and external audits.
Oversee maintenance of annual licenses, listings, and patent information.

Qualifications

Required

Bachelor’s degree or equivalent education/experience.
4–5 years’ experience in a regulated industry (medical products, nutritionals, etc.).
Strong written, verbal, organizational, and presentation skills.
Scientific writing experience.
Ability to manage multiple competing priorities.

Preferred

Bachelor’s degree in Biology, Chemistry, Microbiology, Immunology, Medical Technology, Pharmacy, Pharmacology, Math, Engineering, or related medical/scientific field.
Advanced degree in Engineering, Sciences, or related discipline.
8+ years’ experience in FDA submissions (PMA, IDE, 510(k)) for Class II/III devices or EU/Canada Class III & IV License Applications.
Experience with Class III IDE/PMA submissions, EU Technical Files, or Canada Class III & IV applications.
Experience in cross-functional, geographically diverse, matrixed organizations.
Knowledge of QSR, ISO, EN standards.
Strong analytical and problem-solving skills.
Effective negotiation and communication with regulatory agencies.

Compensation

Base Salary Range: $112,000 – $224,000 (may vary by location).

Equal Opportunity Statement

Abbott is an Equal Opportunity Employer committed to employee diversity.

Connect with Abbott

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Regulatory Affairs Manager – Canada & Latin America

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