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Regulatory affairs associate Jobs in Sunnyvale, CA

Last updated: 8 hours ago
  • Promoted
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Kelly Science, Engineering, Technology & TelecomSunnyvale, CA, United States
$47.00–$50.00 hourly
Full-time
Regulatory Affairs Specialist I.The Regulatory Affairs Specialist I, NPD is responsible for evaluating and ensuring labeling accuracy for client's in vitro diagnostic products.This role offers a un...Show moreLast updated: 5 days ago
  • Promoted
Senior Director Regulatory Affairs

Senior Director Regulatory Affairs

Pulmonx CorporationSan Jose, CA, US
$200,000.00–$240,000.00 yearly
Full-time
Director of Regulatory Affairs.Director level depending upon experience.Workplace type : Hybrid (Remote will be considered for candidates in the western US). Responsibilities and Capabilities : .Create...Show moreLast updated: 7 days ago
Regulatory Affairs Intern

Regulatory Affairs Intern

IntuitiveSunnyvale, CA, US
At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care.Through ingenuity and intelligent technology, we expand the potential of physicians to...Show moreLast updated: 30+ days ago
Regulatory Affairs Specialist

Regulatory Affairs Specialist

R&D PartnersCalifornia, CA
R&D Partners is seeking to hire a.Regulatory Affairs Specialist II.Your main responsibilities as a.Regulatory Affairs Specialist II : . Compile and maintain regulatory documentation databases or syste...Show moreLast updated: 30+ days ago
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Regulatory Affairs Senior Associate

Regulatory Affairs Senior Associate

VirtualVocationsSunnyvale, California, United States
Full-time
A company is looking for a Senior Associate - Regulatory Affairs.Key Responsibilities : Develop and execute the global regulatory product strategyLead Global Regulatory Teams (GRTs) and represent Reg...Show moreLast updated: 3 days ago
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Vice President Regulatory Affairs

Vice President Regulatory Affairs

MeetSan Jose, CA, United States
Full-time
Vice President, Regulatory Affairs.Hybrid Workstyle (2-3x per week onsite in South San Francisco, CA).Meet has partnered with an exciting biotech that is looking for a Vice President of Regulatory ...Show moreLast updated: 5 days ago
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  • New!
Executive Director, Regulatory Affairs

Executive Director, Regulatory Affairs

Trebla TalentSanta Clara, CA, US
Full-time
Senior Director / Executive Director of Regulatory Affairs.Bay Area (Remote - West Coast Preferred).This late-stage clinical biotech is pioneering a new class of complementary medicines for patients ...Show moreLast updated: 14 hours ago
Regulatory Affairs Intern

Regulatory Affairs Intern

Intuitive SurgicalSunnyvale, CA, United States
$41,600.00–$74,880.00 yearly
Full-time
At Intuitive, we are united behind our mission : we believe that minimally invasive care is life-enhancing care.Through ingenuity and intelligent technology, we expand the potential of physicians to...Show moreLast updated: 30+ days ago
  • Promoted
OUS APAC Regulatory Affairs Lead

OUS APAC Regulatory Affairs Lead

AppleCupertino, California, US
$168,200.00–$280,200.00 yearly
Full-time
Skills, Experience, Qualifications, If you have the right match for this opportunity, then make sure to apply today.Our ever-evolving suite of Health and Wellness products for iPhone and Watch are ...Show moreLast updated: 2 days ago
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Associate Director, Regulatory Affairs : Job ID - 1435

Associate Director, Regulatory Affairs : Job ID - 1435

Ascendis Pharma A / SPalo Alto, California, US
$190,000.00–$215,000.00 yearly
Full-time
Denmark, Europe, and the United States.Today, we're advancing programs in Endocrinology Rare Disease and Oncology.Interested in learning more about this job Scroll down and find out what skills, ex...Show moreLast updated: 2 days ago
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Regulatory Affairs Manager

Regulatory Affairs Manager

Ipro Networks Pte. Ltd.Sunnyvale, California, US
$100,000.00–$150,000.00 yearly
Full-time
Ready to make your application Please do read through the description at least once before clicking on Apply.Salary - $100k - $150k + Benefits. Bachelor’s degree in Science, Engineering, Math, a med...Show moreLast updated: 2 days ago
Regulatory Affairs Analyst

Regulatory Affairs Analyst

San Jose Water CompanySan Jose, CA, US
Founded in 1866, San Jose Water Company is an investor owned water company headquartered in Silicon Valley.With a service area of 140 square miles, it is one of the largest and most technically sop...Show moreLast updated: 30+ days ago
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Katalyst HealthCares & Life SciencesSan Jose, CA
Work with cross-functional teams to provide regulatory guidance during the development of Class III Medical Devices.Establish the regulatory strategy and global registration plan for products, meet...Show moreLast updated: 30+ days ago
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Kelly ServicesSunnyvale, CA, US
$47.00–$50.00 hourly
Full-time
Regulatory Affairs Specialist I.The Regulatory Affairs Specialist I, NPD is responsible for evaluating and ensuring labeling accuracy for client's in vitro diagnostic products.This role offers a un...Show moreLast updated: 1 day ago
Regulatory Affairs Manager

Regulatory Affairs Manager

Guardant HealthPalo Alto, CA, us
$131,100.00–$177,000.00 yearly
Full-time
This role will actively support development and implementation of regulatory strategies, premarket submissions, post-market change submissions, annual reports, labeling review, and other related ac...Show moreLast updated: 30+ days ago
  • Promoted
Regulatory Affairs Specialist

Regulatory Affairs Specialist

ACE PartnersSan Jose, CA, United States
$110,000.00–$120,000.00 yearly
Full-time
Regulatory Affairs Specialist – Medical Devices.Working knowledge of FDA 510(k) submissions is a must.This role offers an exciting opportunity to contribute to regulatory compliance and support a c...Show moreLast updated: 11 days ago
  • Promoted
(Senior) Director, International Regulatory Affairs

(Senior) Director, International Regulatory Affairs

Proclinical StaffingSunnyvale, CA, US
Permanent
Senior) Director, International Regulatory Affairs – Permanent – San Francisco Bay Area.Proclinical is seeking a (Senior) Director, International Regulatory Affairs for a growing biopharmaceutical ...Show moreLast updated: 16 days ago
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  • New!
Regulatory Affairs Specialist

Regulatory Affairs Specialist

The Ranger GroupSanta Clara County, CA, United States
Full-time
Ranger has a Contract to Hire opportunity for a Regulatory Specialist with one our large Medical Device customers in the Bay Area. The role would start on a Contract basis with the goal of convertin...Show moreLast updated: 8 hours ago
Regulatory Affairs

Regulatory Affairs

The Judge GroupPalo Alto, CA
$68.00 hourly
Our client is currently seeking a Regulatory Affairs for a 12 month + contract.Hybrid position, 2 days in office (Palo Alto, CA). Position Description : •Perform the coordination and preparation of r...Show moreLast updated: 30+ days ago
  • Promoted
Senior Associate, Regulatory Affairs

Senior Associate, Regulatory Affairs

Bayside SolutionsSan Mateo County, CA, United States
$83,200.00–$104,000.00 yearly
Full-time
Senior Associate, Regulatory Affairs.Redwood City, CA - Hybrid Role.As a Senior Associate of Regulatory Affairs, you will support Regulatory Affairs management in the day-to-day operational aspect ...Show moreLast updated: 19 days ago
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Kelly Science, Engineering, Technology & TelecomSunnyvale, CA, United States
5 days ago
Salary
$47.00–$50.00 hourly
Job type
  • Full-time
Job description

Regulatory Affairs Specialist I

Overview :

The Regulatory Affairs Specialist I, NPD is responsible for evaluating and ensuring labeling accuracy for client's in vitro diagnostic products. This role offers a unique opportunity to collaborate with cross-functional teams, including Technical Publications, Product Transfer, Quality, R&D, and Clinical Affairs, as part of client's global change control process. The position ensures regulatory compliance of product labeling and offers exposure to diverse array of in vitro diagnostic products, innovative technologies, and tools that implement continuous improvements and introduce new products to market.

Location : Sunnyvale, CA (Onsite)

Shift : M-F, standard working hours

Contract Duration : 3 months

Pay : $47-$50 / hr

Responsibilities

  • Familiarization : Understand client's global change control process.
  • Review and Implementation : Review change plans and implemented changes to product labeling / instructions for use.
  • Cross-functional Collaboration : Partner with stakeholders to ensure accuracy in labeling changes.
  • Regulatory Compliance : Work with the Technical Publications team to publish regulatory-compliant labeling for products.

Requirements :

  • Bachelor's degree with 2+ years of related work experience
  • Understanding of QMS regulations and standards (21 CFR Part 820 and EN ISO 13485) governing change management and CAPA.
  • Preferred Requirements :

  • Experience with Agile documentation systems.