Regulatory Affairs Specialist jobs in Vallejo, CA

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

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Regulatory Affairs Specialist
  • Synergy Solutions
  • Hercules, CA CONTRACTOR
  • Initial 6 month contract with possible extensions and/or conversion to permanent employment.

    • This position will perform international registration for medical diagnostic equipment.
    • Administrative duties in Trackwise digital database
    • Respond to incoming requests for international registrations and provide country registration documentation according to schedule.
    • Work with regulatory specialist team to learn and provide primary documentation that is required for each country registration worldwide.
    • Update project team on current status of registration for medical devices.

    Qualifications:

    • B/A degree and 2 years of relevant experience
    • Previous experience with both IVD, and EU MDR
    • Registration documentation for medical diagnostic equipment
    • Previous TRACKWISE experience
    • Experience with word, excel and Document Control in a regulated environment.

    Job Disclaimer:

    Equal Opportunity Employer/Veterans/Disabled

    Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client

    To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/

    The Company will consider qualified applicants with arrest and conviction records.

    Job Type: Contract

    Pay: $40.00 - $50.00 per hour

    Expected hours: 40 per week

    Benefits:

    • 401(k)
    • Dental insurance
    • Health insurance
    • Paid time off
    • Vision insurance

    Experience level:

    • 2 years

    Schedule:

    • 8 hour shift
    • Day shift
    • Monday to Friday

    Education:

    • Bachelor's (Required)

    Experience:

    • Regulatory Affairs: 2 years (Required)
    • In Vitro Diagnostics: 2 years (Required)
    • Registration Documentation: 2 years (Required)
    • Trackwise: 2 years (Required)

    Ability to Relocate:

    • Hercules, CA 94547: Relocate before starting work (Required)

    Work Location: In person

  • 14 Days Ago

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Regulatory Affairs Specialist - Hercules CA (IVD Medical Device Industry Experie
  • Advantage Technical
  • Hercules, CA FULL_TIME
  • Advantage Technical is seeking a RA Specialist for our client in Hercules, CA. This is for a top-five life science company in the world! Do you have what it takes? *Provide regulatory support for IVD ...
  • 15 Days Ago

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Regulatory Affairs Manager
  • Cerus Corporation
  • Concord, CA FULL_TIME
  • About Cerus: Cerus aims to be the global leader and trusted partner of blood centers and hospitals whose technology, services, and commitment are the lifeblood of safe and accessible blood for patient...
  • 23 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Napa, CA FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 11 Days Ago

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Clinical Trial Regulatory Specialist I- Vallejo
  • Kaiser Permanente
  • Vallejo, CA OTHER
  • Job Summary: The Clinical Trial Regulatory Specialist I (CTRS-I) is a novice level position which, under the direction of the KPNC Clinical Trials Compliance Director or designee and Principal Investi...
  • 24 Days Ago

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Chemical Regulatory Software Engineer
  • henkel1-pilot
  • Concord, CA FULL_TIME
  • HENKEL IS FOR THOSE WHO STEP UP. DO YOU? At Henkel, you can make a difference and craft your career. That’s why you own your projects and take full responsibility from an early stage. Our unique brand...
  • 19 Days Ago

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0 Regulatory Affairs Specialist jobs found in Vallejo, CA area

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RA Specialist I
  • TPS Group
  • Hercules, CA
  • RA Specialist I Hercules, California 12 month assignment (potential to extend) Pay Rate: $35-40/hour Essential Onsite-M-...
  • 3/29/2024 12:00:00 AM

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Material Handler - Temp
  • Bio-Rad Laboratories, Inc.
  • San Francisco, CA
  • **Material Handler - Temp** ** Material Handler - Temp** * 2022-27131 * Richmond, California, United States The Material...
  • 3/29/2024 12:00:00 AM

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Regulatory Affairs Specialist II - Heart Failure
  • Abbott
  • Pleasanton, CA
  • Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
  • 3/28/2024 12:00:00 AM

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Construction Consulting Associate
  • Exponent Inc.
  • Oakland, CA
  • About Exponent: Exponent is the only premium engineering and scientific consulting firm with the depth and breadth of ex...
  • 3/28/2024 12:00:00 AM

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Electrical Engineer or Physicist with a Background in Energy Systems (Ph.D.)
  • Exponent Inc.
  • Oakland, CA
  • About Exponent: Exponent is the only premium engineering and scientific consulting firm with the depth and breadth of ex...
  • 3/28/2024 12:00:00 AM

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Personal Banker Roving - Diablo Valley District
  • WELLS FARGO BANK
  • Pleasant Hill, CA
  • Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company known for our "W...
  • 3/27/2024 12:00:00 AM

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Regulatory Affairs Specialist II - APAC - Diabetes Care
  • Abbott
  • Alameda, CA
  • Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-chan...
  • 3/26/2024 12:00:00 AM

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Personal Banker - Roving Napa Sonoma District
  • WELLS FARGO BANK
  • Sonoma, CA
  • Why Wells Fargo: Are you ready for the next step in your career? This is where it begins - at a company known for our "W...
  • 3/25/2024 12:00:00 AM

Vallejo (/vəˈleɪ(h)oʊ/ və-LAY-(h)oh; Spanish: [baˈʎexo]) is a waterfront city in Solano County, California, located in the North Bay subregion of the San Francisco Bay Area. Vallejo is geographically the closest North Bay city to the inner East Bay, so it is sometimes associated with that region. Its population was 115,942 at the 2010 census. It is the tenth most populous city in the San Francisco Bay Area, and the largest in Solano County. Vallejo sits on the northeastern shore of San Pablo Bay, 30 miles north of San Francisco, the northwestern shore of the Carquinez Strait and the southern e...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$85,162 to $114,128
Vallejo, California area prices
were up 2.5% from a year ago

Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020