Principal Regulatory Affairs Specialist – APAC, Diabetes Care
Location: Alameda, California, United States
Employment Type: Full-Time, On-Site
Category: Regulatory Affairs
Experience Required: 5+ years in regulatory affairs, with focus on medical devices, in vitro diagnostics, or pharmaceuticals
About Abbott
Abbott is a global healthcare leader committed to helping people live healthier, fuller lives. Our portfolio spans diagnostics, medical devices, nutritionals, and branded generics, impacting millions of patients worldwide. With over 114,000 colleagues in more than 160 countries, Abbott is dedicated to innovation, patient-centered solutions, and regulatory excellence.
Abbott’s Diabetes Care division develops cutting-edge technologies that empower patients to manage glucose levels effectively, improve health outcomes, and make informed decisions through advanced sensing and monitoring solutions.
Role Overview
Abbott is seeking a Principal Regulatory Affairs Specialist – APAC to join our Diabetes Care Division at the Alameda, CA location. This senior-level role leads regulatory strategy and execution for Asia Pacific (APAC) markets, ensuring timely product registration, compliance, and release. The specialist will drive cross-functional collaboration, manage regulatory risk, and optimize processes to support the introduction of life-changing diabetes care products.
Key Responsibilities
Lead strategic planning and execution of product registration and release in APAC markets.
Oversee regulatory processes and team efforts to ensure compliant product launch and ongoing approvals.
Drive engagement with regulatory authorities, facilitating clear communication of complex technical information.
Collaborate with cross-functional teams including Regulatory Affairs (APAC, CALA, EMEAP, US), Commercial, Marketing, Supply Planning, Quality, R&D, Operations, and Customer Service.
Own product release processes, developing tools and processes for controlled, efficient product launches.
Provide regulatory input for product lifecycle planning and project strategy based on evolving regulations.
Monitor emerging regulatory issues and guide teams in compliance and risk mitigation.
Act as liaison across departments including Quality, R&D, Legal, Operations, Marketing, and Clinical Affairs.
Hire, retain, and develop a diverse, high-performing regulatory team, providing ongoing coaching and feedback.
Ensure compliance with FDA and international regulatory requirements, company policies, and Quality Management Systems (QMS) and Environmental Management Systems (EMS).
Required Qualifications
Bachelor’s degree in a scientific discipline (Chemistry, Life Sciences, Biology, or equivalent).
Proven experience in regulatory submissions for pharmaceuticals, in vitro diagnostic devices, or medical devices.
Knowledge of 21 CFR 820, ISO 13485, Medical Devices Directive (93/42/EEC), and/or IVD Directive (98/79/EC).
Strong verbal and written communication skills, with ability to present effectively at multiple organizational levels.
Preferred Qualifications
Advanced degree (Master’s, MBA, or PhD) in a technical, regulatory, or scientific field.
Minimum 5 years of experience in regulatory affairs.
Scientific writing and documentation expertise.
In-depth understanding of EU MDR (Regulation EU 2017/745) and IVDR (Regulation EU 2017/746).
Experience within an ISO 13485-certified Quality Management System.
Proven experience with international product registration, with a focus on APAC markets.
Fluency in Chinese is highly desirable.
RAC certification or equivalent professional regulatory certification is a plus.
Benefits & Career Growth
At Abbott, employees enjoy:
Career development and training programs, including tuition assistance.
Comprehensive healthcare benefits including medical, dental, vision, and wellness programs.
Retirement plans with generous company match.
Paid time off and flexible work options.
Opportunity to contribute to innovative diabetes care solutions impacting millions globally.
Learn more about Abbott’s benefits: www.abbottbenefits.com
Why Join Abbott
Abbott provides a platform for regulatory professionals to lead global initiatives, build expertise, and impact patient care worldwide. Abbott is an Equal Opportunity Employer, committed to diversity, equity, and inclusion.
Base Salary: $98,000 – $196,000 (location-dependent)
Apply Now to take your regulatory affairs career to the next level with Abbott.
Gujarat :
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Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | India | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Mcallen | North Richland Hills | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |California :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Bulgaria | Vedant |Denmark :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
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Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Nedlands |Queensland :
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South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
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Argentina | Peru |Brazil :
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Greece |North Island :
Auckland |New Zealand :
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Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
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Japan | Saitama |Tokyo :
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Bangkok |Israel :
Tel Aviv | Be'Er Sheva | Netanya | Yavne | Kfar Saba |Remote :
Hammond | Regulatory Labeling Manager (NA and LATAM Only) | Remote | Remote - Africa | Remote - South America (Latin Americal) | Xzagreb | Belgium | Riga | Minnesota | French | Lousiana | Lenexa | Thailand | Ireland | Blue Bell | Remote, USA | Remote - Europe | McFarland | Faridabad | Castlebar | Zaragoza | Nairobi | Switzerland | Slovakia | Bishop | Manipal | Springville | Melbourne | Hungary | Leinster | Texas | Tulsa | Green Way | Bountiful | Victoria | Remote - Middle East | Medan |Republic of Colombia :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
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