Regulatory Affairs Manager – Apac - Diabetes Care (On-Site)

4-5 years

$112,000.00 – $224,000.00

Alameda

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

Regulatory Affairs Manager – APAC - Diabetes Care (On-Site)

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

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. Our portfolio of life-changing technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines. With 114,000 employees in over 160 countries, we are dedicated to enhancing lives at all stages.

Working at Abbott

At Abbott, you can:

Grow and develop your career with an international company.
Qualify for free medical coverage under the 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 at a company recognized as a best place to work globally and named one of the most admired companies by Fortune.

The Opportunity

The Regulatory Affairs Manager – APAC will be based on-site in Alameda, CA, within Abbott’s Diabetes Care Division. This role involves working closely with in-country regulatory representatives in the Asia Pacific (APAC) region to ensure regulatory compliance. You will be responsible for managing a small team overseeing the Diabetes Care product portfolio, developing global regulatory strategies, and supporting regulatory submissions for product registration in the APAC region.

Responsibilities

Manage a team of regulatory specialists.
Develop and advance policies and procedures for regulatory affairs and compliance.
Represent Regulatory Affairs on cross-functional teams, providing strategic input on APAC regulatory requirements.
Propose strategies on complex regulatory issues using technical expertise.
Work closely with in-country regulatory representatives to prepare and review medical device or IVD submissions.
Address regulatory authority queries and provide strategic guidance.
Evaluate product design and manufacturing changes for regulatory impact.
Maintain compliance with post-marketing approval requirements.
Oversee annual licenses, registrations, and listings.
Review product labeling and promotional materials for compliance.
Support internal and external audits.

Required Qualifications

Bachelor’s degree OR equivalent combination of education and experience.
4-5 years of experience in a regulated industry (e.g., medical products, nutritionals).
2-5 years of experience in regulatory affairs preferred; may also consider experience in quality assurance, R&D, scientific affairs, or operations.
Strong verbal and written communication skills with the ability to present at multiple levels.

Preferred Qualifications

Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or a medical field.
Master’s degree in a technical area or MBA; PhD or law degree is a plus.
5+ years of experience in regulatory affairs.
Supervisory experience.
Strong knowledge of ISO and EN standards and APAC region-specific regulatory requirements.
Certification (e.g., RAC from the Regulatory Affairs Professionals Society) is a plus.

Compensation & Benefits

Base Pay: $112,000.00 – $224,000.00 (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 employee diversity.

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Regulatory Affairs Manager – Apac - Diabetes Care (On-Site)

Job Description

About Abbott

Working at Abbott

The Opportunity

Responsibilities

Required Qualifications

Preferred Qualifications

Compensation & Benefits

Apply Now

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