Medical Events Specialist I

Abbott

1+ years

$79,500 – $138,700

California United States

10 Dec. 15, 2025

Job Description

Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Medical Events Specialist I – Regulatory Affairs

Location: Alameda, California, United States
Category: Regulatory Affairs / Pharmacovigilance
Employment Type: Full-Time, On-Site
Experience Required: 1+ year in regulatory or medical device vigilance reporting

About Abbott

Abbott is a global healthcare leader delivering innovations that help people live healthier, fuller lives. Our diverse portfolio spans diagnostics, medical devices, nutritionals, and branded generics, impacting millions globally. With over 114,000 employees across 160+ countries, Abbott fosters a culture of innovation, regulatory excellence, and operational integrity.

Abbott’s Diabetes Division is committed to transforming diabetes management, providing patients with accurate, actionable data through advanced sensing technologies for better health outcomes.

Role Overview

The Medical Events Specialist I is responsible for the timely review, documentation, and submission of Medical Device Reports (MDRs) and other regulatory filings across global jurisdictions, including the FDA (US), Health Canada, EU/EFTA, and other international markets. This role ensures regulatory compliance, accuracy, and efficiency in handling medical device complaints and reportable events.

Key Responsibilities

Review medical complaints and determine reportability in accordance with applicable regulations.
Collect, validate, and document additional information to support vigilance reporting decisions.
Submit reportable medical events and device malfunctions to regulatory authorities within defined timelines.
Monitor the status of submitted reports and ensure follow-up actions are completed promptly.
Collaborate with internal teams such as Customer Service, Complaint Evaluation, and Investigation groups to gather relevant information.
Provide feedback and recommendations to improve complaint documentation and reporting processes.
Maintain the Malfunction Reportability Assessment Matrix (MRAM) and update the Reportable Confirmed Malfunction List (RCML) as required.
Verify MDRs/vigilance reports and support compilation of metrics, risk evaluations, and other analyses.
Stay current with regulatory requirements, internal quality procedures, and global medical device vigilance standards.
Adapt processes and documentation in alignment with updated regulations and industry best practices.
Interface with management and cross-functional teams to ensure timely identification and reporting of Potential Reportable Events (PREs).

Required Qualifications

Bachelor’s Degree in a related field, or equivalent combination of education and experience.
Minimum 1 year of experience in regulatory affairs and 1 year of experience in medical device event reporting.
Strong verbal and written communication skills with the ability to convey complex information clearly.
Detail-oriented with strong organizational and follow-up skills.

Preferred Qualifications

Critical thinking and problem-solving skills to assess reportable events effectively.
Ability to work independently and collaboratively within a fast-paced, changing environment.
Strong multitasking skills and ability to prioritize tasks to meet deadlines.
Familiarity with regulatory requirements for medical device vigilance reporting (e.g., 21 CFR 803, EU MDR).

Why Join Abbott

Impactful Work: Contribute to the safety and efficacy of medical devices used by patients globally.
Career Growth: Access career development, training programs, and tuition assistance.
Comprehensive Benefits: Medical, dental, vision, wellness, and occupational health programs.
Competitive Compensation: Retirement savings, paid time off, and performance-based incentives.
Inclusive Culture: Work at a company recognized globally for diversity, innovation, and employee development.

Learn more about Abbott’s benefits: www.abbottbenefits.com

Abbott is an Equal Opportunity Employer, committed to diversity and inclusion in the workplace.

Base Salary: $79,500 – $138,700 (location-dependent)

Apply Now to join Abbott as a Medical Events Specialist I and help ensure the safety and compliance of medical devices worldwide.

Recommended Jobs

Pharma Jobs in India

Gujarat :

Maharashtra :

Haryana :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Punjab :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | India | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Uttar Pradesh :

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

India :

Siliguri |

Pharma Jobs in United States

Illinois :

Maryland :

Texas :

California :

New York :

New Mexico :

Albuquerque | Farmington | Santa Fe | Tucumcari |

Pennsylvania :

Alaska :

Massachusetts :

Wisconsin :

United states :

Georgia :

Atlanta | Augusta | Rome |

Maine :

Bangor | Brewer |

New Jersey :

Ohio :

LA :

Baton Rouge | Monroe | New Orleans |

Washington :

Oregon :

Wyoming :

Big Piney | Cokeville |

Alabama :

Birmingham |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Indiana :

Bloomington | West Lafayette |

Florida :

Idaho :

Boise |

Colorado :

Boulder | Denver | Westminster |

Connecticut :

North Caroline :

Arizona :

South Carolina :

Charleston |

Kansas :

North Carolina :

Concord | Lumberton | North Carolina |

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

North Dakota :

Dickinson |

Minnesota :

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Arkansas :

Fort Smith |

Kington :

Frank Scottile Blvd |

Missouri :

Fulton | Milan | St. Louis |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Nebraska :

Hebron | Nebraska City |

Hawaii :

Hilo | Honolulu |

Tennessee :

Knoxville | Memphis | Nashville |

Louisiana :

Lake Charles | Shreveport |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Macon | Manchester |

Portugal :

Lisbon | Oeiras | Portugal |

WI :

Madison | Wausau |

Republic of Mexico :

Mexico |

northeastern :

New Hampshire |

Oklahoma :

Oklahoma City |

Puerto Rico :

San Juan |

Albama :

Tuscaloosa |

D.C :

Washington |

Delaware :

Wilmington |

Pharma Jobs in Germany

North Rhine Westphalia :

Munich :

Bavaria |

Bavaria :

Brandenburg :

Berlin |

Baden-Wurttemberg :

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Germany :

Germany | GErmany |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Saxony Anhalt :

Halle |

Rotherbaum :

Hamburg |

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Schleswig Holstein :

Kiel |

Berlin :

Mitte |

Mecklenburg Vorpommern :

Rostock |

Saarland :

Saarbrucken |

Pharma Jobs in Europe

Switzerland :

Basel | Zurich |

Serbia :

Belgrade | Serbia |

Hungary :

Budapest |

BULGARIA :

Bulgaria | Vedant |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Belgium :

Wavre |

Pharma Jobs in Ireland

Tipperary :

Ballydine |

Cork :

Brinny | Ringaskiddy |

Carlow :

Carlow |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Meath :

Dunboyne |

Dún Laoghaire :

Dún Laoghaire |

Galway :

Galway |

County Dublin :

Swords |

Pharma Jobs in China

Republic of China :

Beijing |

China :

China | Quarry Bay |

Liaoning :

Dalian |

Zhejiang :

Hangzhou |

Tokiyo :

Osaka | Tokyo |

Shanghai Sai :

Shanghai Shi |

Hubei :

Wuhan |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

North Brabant :

Breda |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Netherlands :

Netherlands |

Pharma Jobs in Australia

Remote Australia :

Arkansas | Remote Australia |

New South Wales :

Ballina | Sydney |

Republic of Western Australia :

Nedlands |

Queensland :

Queensland |

Melbourne :

South Yarra |

Pharma Jobs in United Kingdom

Surrey :

Chessington | Pirbright |

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Pharma Jobs in England

United Kingdom :

North Yorkshire :

Harrogate |

South Yorkshire :

Sheffield |

Oxfordshire :

Witney |

Pharma Jobs in Canada & Belgium & South America & Greece & New Zealand & Austria & Spain & Philippines & Croatia & Estonia & Vietnam & Italy & Indonesia & Japan & Finland & Korea & Kazakhstan & Thailand & Israel & Remote & Colombia & Tennessee & Romania & Argentina & Egypt & Mexico & United Arab Emirates & Saudi Arabia & malaysia & Ukraine & Peru & France & South Afrcia & Serbia & Czechia & Chile & Bosnia and Herzegovina & Singapore & Bulgaria & Sweden & Taiwan & Poland

Ontario :

Canada :

Canada |

Quebec :

Montreal |

Brussels :

Brussels |

Antwerp :

Heist op den Berg |

Flemish Brabant :

Zaventem |

South America :

Peru | Argentina |

Brazil :

Sao paulo | Brazil |

Attica :

Athens | Koropi |

Greece :

Greece |

North Island :

Auckland |

New Zealand :

New Zealand |

Austria :

Austria |

Vienna :

Vienna |

Catalonia :

Barcelona |

Madrid :

Madrid |

Cebu Province :

Cebu City |

Philippines :

Manila |

Croatia :

Croatia |

Zagreb :

Zagreb |

Estonia :

Tartu | Estonia |

Harju County (Maakond) :

Tallinn |

Hà Nội :

Hà Nội | Hanoi |

Ho Chi Minh :

Ho Chi Minh City |

Italy :

Italy |

Lombardy :

Rho |

Jakarta :

Jakarta |

East Java :

Surabaya |

Japan :

Saitama | Japan |

Tokyo :

Otemachi |

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kazakhstan :

Almaty |

Republic of Thailand :

Bangkok |

Israel :

Remote :

Republic of Colombia :

Bogota |

Williamson :

Brentwood |

Bucharest :

Bucharest |

Buenos Aires :

Buenos Aires |

Republic of Egypt :

Cairo |

Mexico :

Ciudad de México | New Mexico |

Dubai :

Dubai |

Makkah :

Kuala Lumpur :

Kuala Lumpur |

Kyiv Oblast :

Kyiv |

Lima Region :

Lima |

France :

Lyon | Paris |

South Africa :

South Africa | Midrand |

Nišava District :

Niš |

Bohemia :

Prague |

Chile :

Santiago |

Bosnia and Herzegovina :

Sarajevo |

Singapore :

Singapore |

Sofia City :

Sofia |

Sweden :

Sweden |

Taipei :

Taipei |

Mazovia :

Warsaw |

Welcome Back

Create Account

Medical Events Specialist I

Job Description

Recommended Jobs

Medical Writer Ii ((Funding E-Request)

Medical Director/Clinical Trial Physician - Neurology(Client Dedicated)

Associate Medical Director/Medical Director - Rheumatology/Dermatology

Associate Medical Director/Med Dir - Neurology

Associate Medical Director/Med Dir - Neurology

Associate Medical Director/Medical Director - Gastroenterology/Hepatology

Associate Medical Director/Medical Director - Cardiology

Global Medical Safety Lead(Medical Director) - Remote U.S/Canada

Quality Assurance Specialist, Medical Communications

Senior Medical Safety Advisor