Motion Recruitment Partners, LLC
Motion Recruitment Partners, LLC

Senior Regulatory Affairs Specialist

Remote in Irvine, CA, US • Posted 8 hours ago • Updated 8 hours ago
Full Time
On-site
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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 8 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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