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.
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Mangaluru | Mysore | Udupi |Kerala :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Odisha :
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Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Uttar Pradesh :
Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |West Bengal :
Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
Tuscaloosa |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
Fort Smith |California :
Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
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Wilmington |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Georgia :
Atlanta | Augusta | Rome |Hawaii :
Hilo | Honolulu |Idaho :
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Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Indiana :
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Bangor | Brewer |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
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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 | New Brunswick | Newark | 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 | West Orange | Westfield | Wharton | Whippany |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |New York :
Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |North Carolina :
Concord | Lumberton | North Carolina |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |North Dakota :
Dickinson |northeastern :
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Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |Oklahoma :
Oklahoma City |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Pennsylvania :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Pottstown | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Portugal :
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Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |United States :
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Blacksburg | Charlottesville | Falls Church | Mechanicsville |Washington :
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Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |Wyoming :
Big Piney | Cokeville |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
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Berlin |Germany :
Germany | GErmany |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Rotherbaum :
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Kiel |Belgium :
Wavre |BULGARIA :
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Copenhagen | Denmark |Europe :
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Dunboyne |Republic of Ireland :
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China | Quarry Bay |Hubei :
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Dalian |Republic of China :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
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Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
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Montreal |Chile :
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Croatia |Zagreb :
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Prague |Republic of Egypt :
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Paris | Lyon |Attica :
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Jakarta |Israel :
Tel Aviv | Yavne | Netanya | Be'Er Sheva | Kfar Saba |Italy :
Italy |Lombardy :
Rho |Japan :
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Ciudad de México |North Island :
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McFarland | Manipal | Nairobi | Thailand | Tulsa | Hungary | Faridabad | Minnesota | Switzerland | Bountiful | Medan | Remote | Belgium | Melbourne | Lousiana | Texas | Hammond | Slovakia | Remote - South America (Latin Americal) | Bishop | Castlebar | Remote - Europe | Zaragoza | Remote - Africa | Remote, USA | Victoria | Riga | Green Way | Ireland | Remote - Middle East | French | Springville | Blue Bell | Leinster | Xzagreb | Lenexa |Bucharest :
Bucharest |Makkah :
Rabigh | Riyadh | Najran | Khulais | King Abdullah Economic City | Jeddah |Nišava District :
Niš |Singapore :
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Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
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Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |