Regulatory Relations Specialist jobs in Fremont, CA

Regulatory Relations Specialist files applications and interacts with governmental officials during the regulation and certification process for a plant or other facility. Assists in developing procedures to ensure regulatory compliance. Being a Regulatory Relations Specialist gathers data pertaining to organizational projects and their impact on the regulation process. May require a bachelor's degree. Additionally, Regulatory Relations Specialist typically reports to a supervisor or manager. To be a Regulatory Relations Specialist typically requires 4 to 7 years of related experience. Contributes to moderately complex aspects of a project. Work is generally independent and collaborative in nature. (Copyright 2024 Salary.com)

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Regulatory Specialist II
  • Mindlance
  • Santa Clara, CA FULL_TIME
  • Exempt/Non Exempt: Non Exempt Years Experience: 2-5 years regulatory experience and/or 2 years relevant industrial experience typically with a quality, product-development/support, or scientific affairs function Skills: Knowledge of regulations and standards affecting IVDs and/or biologics Education: BS preferred in a technical discipline like biology, chemistry, microbiology, immunology, medical technology, etc.Duties: Responsible for implementing and maintaining the effectiveness of the quality system. Supports manufacturing/operations day to day activities for change control. Provides consultation/advice to regulatory specialist for change control and product development. Provides regulatory direction/interpretation on team activities. Interprets and applies regulatory understanding to support of products and teams. Prepares U.S. regulatory submissions and/or registration documents for international affiliates and government agencies worldwide. Handles regulatory activities involved in documentation,labeling,field support. Applies regulatory and technical knowledge to a wide variety of complex work assignments. Maintains and ensures compliance to the appropriate quality system for the specific medical device(s) designed or manufactured that the individual supports. Ensures compliance to and is able to demonstrate knowledge of site and division level policies and procedures.

    EEO:

    Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.
  • 21 Days Ago

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Regulatory Affairs specialist
  • Katalyst Healthcares & Life Sciences
  • Santa Clara, CA CONTRACTOR
  • Responsibilities: Participate on project teams as regulatory or as RA/QA/CA representative. Develop plans to receive approvals to sell products identified in the marketing sales plan. Maintain knowled...
  • 23 Days Ago

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Principal Regulatory Affairs Specialist
  • Imperative Care Inc
  • Campbell, CA FULL_TIME
  • SUMMARY: Partner with Truvic's functional groups to efficiently deliver accurate, timely, and effective regulatory strategies, documents, deliverables and other projects in line with company objective...
  • 23 Days Ago

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Regulatory Affairs Specialist II
  • Katalyst Healthcares & Life Sciences
  • Redwood City, CA FULL_TIME
  • Responsibilities: You are responsible for regulatory submissions and regulatory compliance for currently marketed products, as necessary, to ensure ongoing compliance Regulatory representative on core...
  • 23 Days Ago

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Regulatory Escalations Specialist
  • Facebook App
  • Sunnyvale, CA FULL_TIME
  • Meta is seeking an Escalations Specialist to join the Detection, Response, and Intelligence- Regulatory Escalations team. The team develops scaled solutions to user issues, protects users by decreasin...
  • 8 Days Ago

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Principal Regulatory Affairs Specialist
  • Recor Medical
  • Palo Alto, CA FULL_TIME
  • At Recor Medical, we are pioneering Ultrasound Renal Denervation (uRDN) therapy to treat hypertension, the leading cardiovascular risk factor in the world. With our Paradise™ uRDN System, we’re on a m...
  • 9 Days Ago

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0 Regulatory Relations Specialist jobs found in Fremont, CA area

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Regulatory Affairs Specialist
  • Intellectt Inc
  • Alameda, CA
  • Role: Regulatory Affairs Associate Location: Alameda, CA Duration: 10+ Months Shift Timings: 8 am to 5 pm Job Descriptio...
  • 4/26/2024 12:00:00 AM

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Regulatory Specialist
  • GForce Life Sciences
  • Alameda, CA
  • Regulatory Affairs Specialist II – On-site in Alameda, CA Qualifications BS in Life Sciences or Medical Engineering/Tech...
  • 4/26/2024 12:00:00 AM

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Regulatory Affairs Specialist – Digital Health Technologies
  • 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...
  • 4/24/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • GForce Life Sciences
  • Santa Clara, CA
  • Regulatory Affairs Specialist– Santa Clara, CA Must be able to work on a W2 Job Summary: We are seeking a regulatory aff...
  • 4/23/2024 12:00:00 AM

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Principal Regulatory Affairs Specialist
  • Planet Pharma
  • Palo Alto, CA
  • Responsibilities and Duties: Acts as technical regulatory lead on core product development teams, communicates regulator...
  • 4/23/2024 12:00:00 AM

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Sr. Regulatory Affairs Specialist - Palo Alto, CA (Hybrid)
  • Hyperfine
  • Palo Alto, CA
  • Company Profile Hyperfine (NASDAQ: HYPR) is the groundbreaking MedTech company that created Swoop, the world's first FDA...
  • 4/23/2024 12:00:00 AM

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Regulatory Affairs Specialist
  • GForce Life Sciences
  • Santa Clara, CA
  • Regulatory Affairs Specialist II – Santa Clara, CA Must be able to work on a W2 Job Summary We're looking for a Regulato...
  • 4/22/2024 12:00:00 AM

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Regulatory Affairs Specialist - Digital Health Technologies
  • 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...
  • 4/22/2024 12:00:00 AM

Fremont (/ˈfriːmɒnt/ FREE-mont) is a city in Alameda County, California, United States. It was incorporated on January 23, 1956, from the annexing of Centerville, Niles, Irvington, Mission San José, and Warm Springs. The city is named after John C. Frémont, an American explorer and former US Senator from California, Governor from Arizona, Major General in the Union Army, and the first Republican presidential candidate, in 1856. Located in the southeast San Francisco Bay Area and straddling both the East Bay and South Bay regions, Fremont has a rapidly-growing population of around 230,000. It i...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Relations Specialist jobs
$93,010 to $127,687
Fremont, California area prices
were up 2.9% from a year ago

Regulatory Relations Specialist in Albany, GA
The Regulatory Relations Specialist is responsible for the execution of the overall strategy for regulatory engagement and enterprise-wide standards.  This includes assisting with the management of regulatory examinations, inquiries and meetings.  Additional responsibilities include.
December 09, 2019
Regulatory Relations Specialist in Monroe, LA
We are looking for a Marketing Specialist to plan, coordinate and manage marketing campaigns and activities across marketing channels.
February 06, 2020