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Senior Regulatory Affairs Specialist

Motion Recruitment Partners, LLC

Remote or Irvine, California • Today

Easy Apply

Full-time

Regulatory Affairs Specialist Small Molecule

Jean Martin, Inc

Remote • 5d ago

Easy Apply

Third Party, Contract

Depends on Experience

Senior US Licensing Engineer - Regulatory Affairs (Remote Eligible, U.S.)

GE Vernova

Remote • Today

Full-time

USD 111,200.00 - 213,200.00 per year

Sr Manager, Global Regulatory Affairs (AI/ML)

Hims and Hers Health, Inc.

Remote • Today

Full-time

USD 170,000.00 - 200,000.00 per year

IT Applications Specialist Sr

Randstad Digital

Remote or Cleveland, Ohio • Today

Contract

USD47 - USD57

ArcGIS Enterprise Platform Specialist / Senior GIS Systems Administrator/ ETL & Development

Svam International, Inc.

Remote • Today

Easy Apply

Contract, Third Party

75 - 80

Senior Specialist, Software Engineering

L3Harris Technologies

Anaheim, California • Today

Full-time

Compensation information provided in the description

Senior Specialist, Software Engineering

Harris Corporation

Anaheim, California • Today

Full-time

USD 122,500.00 - 187,500.00 per year

Sr. Specialist Test Engineer

Harris Corporation

Anaheim, California • Today

Full-time

USD 102,000.00 - 189,000.00 per year

Senior Specialist Systems Engineering - MBSE & Digital Engineering

Harris Corporation

Yorba Linda, California • Today

Full-time

USD 106,500.00 - 197,500.00 per year

Sr. Specialist, Systems Engineering - Radar or Telemetry

Harris Corporation

Yorba Linda, California • Today

Full-time

USD 106,500.00 - 197,500.00 per year

Senior Specialist, Software Engineering

Harris Corporation

Yorba Linda, California • Today

Full-time

USD 111,500.00 - 207,500.00 per year

Sr. Specialist, Systems Engineering - Underwater Acoustics, Telemetry, Comms, Data Recording, Radar

Harris Corporation

Yorba Linda, California • 5d ago

Full-time

USD 106,500.00 - 197,500.00 per year

Senior Specialist, Systems Engineer - Military GPS Receivers

Harris Corporation

Yorba Linda, California • Today

Full-time

USD 106,500.00 - 197,500.00 per year

Senior Specialist, Software Engineer - Application Infrastructure & Embedded Systems

Harris Corporation

Yorba Linda, California • Today

Full-time

USD 111,500.00 - 207,500.00 per year

Contract Business Intelligence Specialist

Ledgent Technology

Irvine, California • Today

Easy Apply

Contract

$30 - $40 per hour

IT Support/Student Learning Specialist

Ledgent Technology

Huntington Beach, California • Today

Easy Apply

Full-time

$60000 - $70000 per annum

Temp IT Support Specialist

Ledgent Technology

Lake Forest, California • Today

Easy Apply

Contract

$27 - $30 per hour

UI/UX Design Specialist

Ledgent Technology

Irvine, California • Today

Easy Apply

Contract

$34 - $37 per hour

Senior Linux and GPU Infrastructure Implementation Specialist

Randstad Digital

Remote or Charlotte, North Carolina • Today

Contract

USD80 - USD100

IT App Development - Senior/Specialist

Washington State Department of Transportation

Remote or Lacey, Washington • Today

Full-time

USD 99,300.00 - 133,608.00 per year

L&I IT Application Development - Senior/Specialist

Washington State Department of Transportation

Remote or Tumwater, Washington • Today

Full-time

USD 99,300.00 - 133,608.00 per year

DO254 Certification specialist

Tanisha Systems, Inc.

Irvine, California • 24d ago

Easy Apply

Full-time, Third Party

Depends on Experience

IT Application Development - Senior/Specialist

Washington State Department of Transportation

Remote or Olympia, Washington • Today

Full-time

USD 99,300.00 - 133,608.00 per year

IT Application Development - Senior/Specialist (Olympia)

Washington State Department of Transportation

Remote or Olympia, Washington • Today

Full-time

USD 99,300.00 - 133,608.00 per year

Applications Support Supervisor (IT Application Development Senior/Specialist)

Washington State Department of Transportation

Remote or Olympia, Washington • Today

Full-time

USD 99,300.00 - 133,608.00 per year

Senior Spectrum Engineer, Regulatory Affairs

Viasat, Inc.

Remote or Carlsbad, California • Today

Full-time

USD 180,500.00 - 285,000.00 per year

Senior Data Governance / Specialist (Alation / Collibra)

HMG America

Remote • Today

Easy Apply

Full-time

$DOE

Senior Contract Specialist/Administrator III

Omm IT Solutions

Remote • 25d ago

Easy Apply

Full-time

Depends on Experience

SAP Functional Analyst Sr./ SAP PaPM Solution Specialist- Remote

Voto Consulting LLC

Remote • 7d ago

Easy Apply

Contract, Third Party

Depends on Experience

Motion Recruitment Partners, LLC

Job Details

Skills

Science
Product Development
Marketing
Documentation
Management
Regulatory Compliance
Policies and Procedures
Biology
Medical Devices
Regulatory Affairs
Negotiations
Communication
Project Management
Conflict Resolution
Problem Solving
Presentations

Summary

Kelly Science and Clinical FSP is currently seeking a Regulatory Affairs Specialist II for a long term engagement in Irvine, CA with one of our Global clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Regulatory Affairs Specialist II

Job Description

Anticipated Start - January 4th

In this role, you will:

Ensure compliance with global regulations and regulating agencies. Interpret the intent of regulations and policies and provide such information to project teams and management.
Develop and implement regulatory strategies and processes to ensure timely global commercialization of products/changes in compliance with applicable regulations and standards.
Develop 510k/PMA submissions and US assessments for class II and III medical devices.
Develop Technical Documentations and EU assessments.
Conduct submission negotiations with the FDA/European Notified Bodies as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval.
Maintain proficiency on regulatory requirements and develop and maintain rapport with FDA/ Notified Body reviewers, project team members.
Represent RA in life cycle management project team.
Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups.
Manage the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by client affiliates.
Work with others as a team player to successfully achieve strategy. Must be cooperative and work well with all functional groups.
Responsible for communicating business related issues or opportunities to next management level.
Responsible for following all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.

Qualifications

A minimum of Bachelor's Degree in Engineering, Physical or Biological science or related field is required.
A minimum of 4 years of experience in Regulatory Affairs or other related discipline in the medical device industry is required. (Or Advanced degree with 2 years of experience in Regulatory Affairs or other related discipline in the medical device industry is required)
Experience of US and/or EU submission is preferred.
Experience in the cardiovascular/cardiology field is preferred.
International clinical and regulatory experience desired.
RA lead on a cross-functional teams (negotiation, leading RA strategy globally) is preferred.
Strong negotiation/communication skill is required.
Strong project management skill is required.
Strong interpersonal, organizational, and problem-solving skills are required.
Strong presentation skill is required.
This position will be located in Irvine, CA.. Domestic and international travel up to 10% may be required.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 10105282
Position Id: 892833
Posted 9 hours ago

Company Info

About Motion Recruitment Partners, LLC

Motion Recruitment delivers IT Talent Solutions for Contract, Direct Hire, Managed Solutions and Statement of Work to all of North America from our 21 delivery centers. Our high-touch, specialized, team-based recruitment model’s success is proven through our exemplary track record in filling the most challenging IT positions for startup and enterprise clients alike. Our hyper-specialized tech focus results in a truly consultative approach for both our clients and candidates, within our recruiting areas of expertise: Software, Mobile, Data, Infrastructure, Cybersecurity, Product + UX and Functional.

Motion also delivers IT Consulting Solutions through the Motion Consulting Group (MCG) that create true digital transformation for IT projects in Agile Development & Coaching, DevOps & DevSecOps Solutions, and Managed Services for IT Operations.

We’re also the proud creators of Tech in Motion and the Timmy Awards, our North American community platform, events series and award program that connects over 250,000 tech enthusiasts to meet, learn, and innovate.

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Motion Recruitment Partners, LLC

Job Details

Skills

Science
Product Development
Marketing
Documentation
Management
Regulatory Compliance
Policies and Procedures
Biology
Medical Devices
Regulatory Affairs
Negotiations
Communication
Project Management
Conflict Resolution
Problem Solving
Presentations

Summary

Ensure compliance with global regulations and regulating agencies. Interpret the intent of regulations and policies and provide such information to project teams and management.
Develop and implement regulatory strategies and processes to ensure timely global commercialization of products/changes in compliance with applicable regulations and standards.
Develop 510k/PMA submissions and US assessments for class II and III medical devices.
Develop Technical Documentations and EU assessments.
Conduct submission negotiations with the FDA/European Notified Bodies as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval.
Maintain proficiency on regulatory requirements and develop and maintain rapport with FDA/ Notified Body reviewers, project team members.
Represent RA in life cycle management project team.
Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups.
Manage the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured and/or distributed by client affiliates.
Work with others as a team player to successfully achieve strategy. Must be cooperative and work well with all functional groups.
Responsible for communicating business related issues or opportunities to next management level.
Responsible for following all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Performs other duties assigned as needed.

Qualifications

A minimum of Bachelor's Degree in Engineering, Physical or Biological science or related field is required.
A minimum of 4 years of experience in Regulatory Affairs or other related discipline in the medical device industry is required. (Or Advanced degree with 2 years of experience in Regulatory Affairs or other related discipline in the medical device industry is required)
Experience of US and/or EU submission is preferred.
Experience in the cardiovascular/cardiology field is preferred.
International clinical and regulatory experience desired.
RA lead on a cross-functional teams (negotiation, leading RA strategy globally) is preferred.
Strong negotiation/communication skill is required.
Strong project management skill is required.
Strong interpersonal, organizational, and problem-solving skills are required.
Strong presentation skill is required.
This position will be located in Irvine, CA.. Domestic and international travel up to 10% may be required.

Dice Id: 10105282
Position Id: 892833
Posted 9 hours ago

Company Info

About Motion Recruitment Partners, LLC

Go to company profile

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

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