Abbott is a global healthcare leader committed to helping people live 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 across more than 160 countries, we are dedicated to improving the health and well-being of people worldwide.
At Abbott, you can:
Do work that matters and grow your career internationally.
Access free medical coverage through the Health Investment Plan (HIP) PPO plan (eligibility starts the following calendar year).
Benefit from an excellent retirement savings plan with a high employer contribution.
Utilize tuition reimbursement, the Freedom 2 Save student debt program, and the FreeU education benefit—affordable pathways to earning a bachelor’s degree.
Join a company recognized globally as a great workplace for diversity, working mothers, female executives, and scientists, as well as one of the most admired companies by Fortune.
Position: Regulatory Affairs Manager – APAC
Location: Alameda, CA (On-site)
Division: Diabetes Care
Abbott’s Diabetes Care Division is revolutionizing glucose monitoring with innovative sensing technology. This role focuses on ensuring compliance and efficiency in regulatory processes across the Asia Pacific (APAC) region. You will manage a small team, create global regulatory strategies, and support cross-functional teams as the regulatory subject matter expert (SME).
Lead and manage a team of regulatory specialists.
Develop and implement policies and procedures for regulatory affairs and compliance.
Represent Regulatory Affairs on cross-functional project teams, providing strategic input and technical guidance on APAC regulatory requirements.
Propose strategies on complex regulatory issues.
Collaborate with in-country regulatory representatives to compile, prepare, and review medical device or IVD submissions.
Provide guidance on regulatory authority queries.
Evaluate design and manufacturing changes for regulatory impact and implement required actions.
Anticipate regulatory challenges and emerging issues throughout the product lifecycle.
Oversee annual licenses, registrations, listings, and patent-related processes.
Ensure compliance with post-marketing product requirements.
Review product labeling and promotional materials for regulatory compliance.
Support internal and external audits.
Bachelor’s degree (or equivalent combination of education and experience).
4–5 years’ experience in a regulated industry (medical products, nutritionals, etc.).
2–5 years’ experience in regulatory affairs preferred (alternatively, experience in quality assurance, R&D/support, scientific affairs, operations, or related areas).
Strong verbal and written communication skills with the ability to present effectively across organizational levels.
Bachelor’s degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields.
Advanced degrees (Master’s, MBA, or PhD in a technical area or law).
5+ years’ experience in regulatory affairs.
Supervisory experience.
Scientific writing experience.
Working knowledge of ISO, EN standards, and country-specific APAC regulations.
Certification such as RAC (Regulatory Affairs Certification) is a plus.
Base pay: $112,000 – $224,000 (may vary by location).
Comprehensive health and wellness benefits to support you and your family.
Career growth opportunities in a global, innovative company.
Abbott is committed to employee diversity and an inclusive workplace.
Website: www.abbott.com
Facebook: www.facebook.com/Abbott
Twitter: @AbbottNews, @AbbottGlobal
Benefits: www.abbottbenefits.com
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