Senior Regulatory Affairs Specialist

3 weeks ago

Pomona, United States Abbott Laboratories Full time

Senior Regulatory Affairs Specialist

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:

  • Career development with an international company where you can grow the career you dream of.

  • Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

  • An excellent retirement savings plan with high employer contribution

  • Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelorâs degree.

  • A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

  • A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.


The Opportunity

The position of Senior Regulatory Affairs Specialist is within our Toxicology Business Unit located in Pomona, CA. This role is responsible for directing and coordinating the implementation of regulatory compliance programs as required by federal, state, and local government agencies. This includes achieving government registration and licensure approval of new products and assuring that current products and manufacturing operations are in compliance with applicable regulations. You will interact with Marketing, Sales Regional Regulatory Affairs staff, regional distributors, governmental regulatory agencies and other third-party accrediting bodies. 

What Youâll Work On

  • Provides regulatory support for commercial in-vitro diagnostic products  

  • Performs regulatory assessment for changes made to the on-market products

  • Understanding of the US 510(k) and EU CE mark (MDR/IVDR) regulatory requirements

  • Develops regulatory strategies to achieve clearance/approval internationally (outside United States)

  • Compiles and publishes all material required for submissions, license renewals, and annual registrations 

  • Works with governmental regulatory agencies and other third-party accrediting bodies 

  • Maintains approvals/licenses/authorizations for existing marketing authorizations

  • Adds and maintains information contained in the Global Regulatory Information Database

  • Provides recommendations on labeling, for regulatory compliance 

  • Develops internal procedures and tools

  • Conducts informational or training sessions for stakeholders

  • Organizes and maintains hard copy and electronic department files

  • Keeps informed of global regulatory information

  • Carries out duties in compliance with established business policies

  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the companyâs policies and practices

  • Demonstrates commitment to the development, implementation and effectiveness of Company Quality Management System per ISO, FDA, and other regulatory agencies

  • Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities

  • Performs other duties and projects as assigned

Required Qualification

  • Bachelorâs degree (BS/BA) in a scientific field

  • 3-5 years of experience in a regulated industry

  • Proficient with Microsoft Office, including Word, Excel, PowerPoint and Visio

  • Able to work on multiple tasks as a team member and/or ability to operate as an individual contributor

  • Must be detail-orientated, self-motivated and available for flexible scheduling

  • Strong written and verbal communication, problem solving and motivational skills

Preferred Qualification

  • 3 years of experience in Regulatory Affairs

  • Three plus years in an IVD or medical device manufacturing environment

  • 510k submission experience

  • Technical file creation and maintenance experience

  • Strong knowledge of US and Foreign regulations

  • Able to work on multiple tasks simultaneously as a team member and/or ability to operate as an individual contributor

  • Possess a high degree of accuracy, detail-orientated, self-motivated and available for flexible scheduling

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.



The base pay for this position is $83,600.00 â $167,200.00. In specific locations, the pay range may vary from the range posted.

  • Senior Regulatory Affairs Specialist

    3 hours ago

    Pomona, California, United States Abbott Laboratories Full time

    About Abbott LaboratoriesAbbott Laboratories is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people...

  • Senior Specialist in Customer Operations

    2 weeks ago

    Pomona, California, United States Electricenergyonline Full time

    Job ID:Join the Clean Energy RevolutionAre you passionate about resolving intricate billing challenges and enhancing customer satisfaction? Do you possess the technical and operational expertise necessary to facilitate the implementation and stabilization of new systems, tools, and processes? If you thrive in a dynamic and collaborative environment where...

  • Culinary Specialist for Senior Living Community

    1 week ago

    Pomona, New Jersey, United States English Meadows Senior Living Full time

    Position OverviewAt English Meadows Senior Living, we are dedicated to enhancing the lives of our Residents through exceptional culinary experiences. Our team of Caregivers is committed to creating a welcoming atmosphere where both Residents and staff thrive.The Culinary Specialist plays a vital role in crafting nutritious and delicious meals sourced from...

  • Clinical Nurse Specialist

    1 week ago

    Pomona, California, United States Biolife Plasma Services Full time

    Job OverviewBy selecting the "Apply" button, I acknowledge that my application process with BioLife Plasma Services will begin, and the information I provide will be handled according to BioLife's Privacy Policy and Terms of Use. I confirm that all details submitted in my application are accurate to the best of my knowledge.Position SummaryNURSING IS A...

  • Clinical Nurse Specialist

    2 weeks ago

    Pomona, California, United States Biolife Plasma Services Full time

    Job OverviewBy selecting the "Apply" button, I acknowledge that my application process with BioLife Plasma Services will begin, and the information I provide will be handled according to BioLife's Privacy Notice and Terms of Use. I affirm that all details submitted in my application are accurate to the best of my knowledge.Position SummaryNURSING CAN BE...

  • Clinical Nurse Specialist

    2 weeks ago

    Pomona, California, United States Biolife Plasma Services Full time

    Job OverviewBy selecting the "Apply" option, I acknowledge that my application process with BioLife Plasma Services will begin, and the information I provide will be handled according to BioLife's Privacy Policy and Terms of Use. I confirm that all details submitted in my application are accurate to the best of my knowledge.Position SummaryNURSING CAN BE...

  • Clinical Nurse Specialist

    2 weeks ago

    Pomona, California, United States Biolife Plasma Services Full time

    Job OverviewBy clicking the "Apply" button, I acknowledge that my employment application process with BioLife Plasma Services will begin, and the information I provide will be handled according to BioLife's Privacy Notice and Terms of Use. I confirm that all information submitted in my application is accurate to the best of my knowledge.Position...

  • Vehicle Fleet Management, Senior Specialist

    2 months ago

    Pomona, United States Edison International Full time

    Get ready to think big, work smart and shine bright! Analyze SAP vehicle data information. Generate SAP reports and compare them to benchmarking data. Assess internal and external client reporting needs. Provide clients with solutions and decisions b Fleet, Management, Vehicle, Specialist, Senior, Operations, Technology

  • Vehicle Fleet Management, Senior Specialist HYBRID

    2 months ago

    Pomona, California, United States Southern California Edison Full time

    Job DescriptionJoin the Clean Energy RevolutionThe Vehicle Fleet Management, Senior Specialist will be responsible for working on multiple assignments and data reports with Fleet Operations and Maintenance Management and other TSD groups, including the garages. Specialist duties will involve maintaining various databases, SharePoint, and operational reports...

  • Fiscal Compliance Analyst for Financial Aid

    2 weeks ago

    Pomona, California, United States CAL Poly Pomona Full time

    Position Title: Financial Aid Fiscal Compliance AnalystWork Type: StaffLocation: PomonaCategories: Unit - CSUEU - Technical Support Services, Probationary, Full Time, Student Services, Telecommute eligible (work onsite as scheduled and/or as requested and telecommute as scheduled)Type of Appointment: Full-Time, ProbationaryJob Classification: Administrative...

  • Lead Project Coordination Specialist

    2 weeks ago

    Pomona, California, United States PM2CM Full time

    Position Overview:We are in search of an experienced Lead Project Coordination Specialist to become a vital member of our innovative team. In this capacity, you will be instrumental in orchestrating and facilitating the implementation of significant organizational projects and initiatives. As a Lead Project Coordination Specialist, you will work in close...

  • Information Governance and Provisioning Senior Specialist-Pomona HYBRID

    1 month ago

    Pomona, California, United States Southern California Edison Full time

    Job DescriptionJoin the Clean Energy RevolutionBecome an Information Governance and Provisioning Sr Specialist at Southern California Edison (SCE) and build a better tomorrow. In this job, you'll will provide technical expertise and perform complex analysis for the T&D Governance and Provisioning organization. The Sr. Specialist is expected to facilitate...

  • Senior Bioconjugation Scientist

    2 weeks ago

    Pomona, California, United States Abbott Full time

    Opportunity at Abbott - Senior Bioconjugation ScientistAbout Abbott: Abbott is a prominent global healthcare organization focused on enhancing lives around the globe. Our commitment to innovation and a diverse range of products drives us to make a significant impact in the healthcare sector. With a workforce of over 114,000 individuals across 160 nations, we...

  • Clinical Nurse Specialist

    2 weeks ago

    Pomona, California, United States Biolife Plasma Services Full time

    Job OverviewBy selecting the "Apply" option, I acknowledge that my application process with BioLife Plasma Services will begin, and the information I provide will be handled according to BioLife's Privacy Policy and Terms of Use. I confirm that all details submitted in my application are accurate to the best of my knowledge.Position SummaryNURSING CAN BE...

  • Senior Project Management Professional

    8 hours ago

    Pomona, California, United States PM2CM Full time

    Job SummaryWe are seeking a highly skilled Senior Project Management Specialist to join our dynamic team at PM2CM. In this role, you will play a pivotal part in coordinating and supporting the execution of major company projects and programs.Key Responsibilities:Collaborate closely with Project Managers to coordinate project activities, track progress, and...

  • Senior Addiction Counselor

    2 weeks ago

    Pomona, California, United States Aegis Treatment Centers Full time

    Senior Addiction Counselor Opportunity at Aegis Treatment CentersAbout Aegis Treatment Centers: Aegis Treatment Centers is a leading provider in the field of addiction recovery services, dedicated to transforming lives through empathetic and professional care. Our methodology is rooted in evidence-based practices, emphasizing the holistic health of our...

  • Diagnostic Imaging Specialist

    5 days ago

    Pomona, New Jersey, United States AtlantiCare Regional Medical Center - Mainland Campus Full time

    Job Summary:AtlantiCare Regional Medical Center - Mainland Campus is seeking a skilled Diagnostic Imaging Specialist to join our team. As a Traveling Sonographer, you will be responsible for performing cardiovascular diagnostic testing according to established departmental procedures.Key Responsibilities:Perform high-quality diagnostic imaging procedures...

  • Senior Physician

    2 days ago

    Pomona, California, United States Apex Ventures Full time

    We are seeking a highly skilled Senior Physician to lead our Child and Adolescent Psychiatry department at Apex Ventures. This is an exciting opportunity to join a dynamic team of medical professionals dedicated to providing exceptional care to our patients.Our department specializes in the diagnosis and treatment of child and adolescent psychiatric...

  • Clinical Nurse Specialist

    2 weeks ago

    Pomona, California, United States Biolife Plasma Services Full time

    Job OverviewBy clicking the "Apply" button, I acknowledge that my employment application process with BioLife Plasma Services will begin, and the information I provide will be processed in accordance with BioLife's Privacy Notice and Terms of Use. I affirm that all information submitted in my application is accurate to the best of my knowledge.Position...

  • Registered Nurse

    3 months ago

    Pomona, United States Biolife Plasma Services Full time

    Job Description NURSING IS HARD WORK. BUT IT DOESN’T HAVE TO BE . At BioLife, nursing can be a challenging, yet fulfilling career. Nursing careers at BioLife are different from many other nursing careers. Here, our Plasma Center Nurses screen and advise donors to ensure they are in good health to donate plasma. In turn, that plasma is used to...