Regulatory Affairs Specialist
Location: [Insert Location]
Base Pay Range: $79,500 – $138,700 (Location-based variations may apply)
About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of technologies spans diagnostics, medical devices, nutritionals, and branded generic medicines. With over 114,000 colleagues serving in 160+ countries, Abbott is recognized worldwide as one of the most admired companies and a top employer for diversity, working mothers, female executives, and scientists.
Why Join Us?
At Abbott, you can do work that matters and live a full life with access to:
Career development with international opportunities.
Free medical coverage (HIP PPO) for qualifying employees.
Excellent retirement savings plan with high employer contribution.
Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefit.
Recognition as a great place to work in dozens of countries worldwide.
The Opportunity
As a Regulatory Affairs Specialist (Individual Contributor), you will support the Regulatory Affairs department by ensuring efficient and compliant business processes. You’ll review labeling, advertising, and promotional materials, determine risks, ensure claims are substantiated, and contribute to regulatory submissions worldwide.
This role provides broad exposure and strong growth potential based on performance.
Key Responsibilities
Promotional & Labeling Compliance
Review and analyze labeling, advertising, and promotional materials.
Partner with Marketing to provide regulatory input and strategy.
Assist with development, review, and compliance approval of promotional content before distribution.
Contribute to SOP development and review for Ad & Promo.
Regulatory Submissions & Approvals
Prepare robust regulatory applications (FDA, Health Canada, EU, Latin America, etc.).
Support new product introductions (NPI) and on-market product activities (510K, PMA).
Review and provide input on device labeling and engineering changes.
Review protocols and reports to support submissions.
Agency & Cross-Functional Collaboration
Interface with FDA and other international regulatory agencies as needed.
Advise cross-functional teams on promotional content and approval requirements.
Maintain current knowledge of global medical device regulations and update submission databases.
Ensure compliance with post-marketing approval requirements.
Compliance & Business Support
Support business initiatives tied to QMS, EMS, and other regulatory requirements.
Review and evaluate communications for compliance with FDA and international standards.
Create and review GTS licenses and requests for product release.
Maintain cooperative communication across teams, customers, vendors, and agencies.
Required Qualifications
Bachelor’s degree (technical discipline preferred).
Minimum 3 years related experience, including 2+ years in regulatory affairs.
Experience with 510(k) applications, PMA supplements, US device regulations, OR with EU/international medical device submissions.
Ability to work in a matrixed, global business environment as both an individual contributor and team member.
Strong communication (verbal/written), organizational, and detail-orientation skills.
Ability to multitask, prioritize, and meet deadlines.
Willingness to travel up to 5% (including internationally).
Preferred Qualifications
Experience in the medical device industry.
Familiarity with Class II or Class III devices.
510(k) submission experience strongly preferred.
Strong problem-solving, strategic thinking, and adaptability.
Process-oriented mindset with ability to shift priorities as needed.
Gujarat :
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Delhi | India | New Delhi | PAN-India |Assam :
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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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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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Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
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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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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
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China | Quarry Bay |Liaoning :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
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Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
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Niš |Bohemia :
Prague |Chile :
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