Job Information
Kelly Services Regulatory Affairs Senior Specialist, Hybrid in Redondo Beach, California
Title : Regulatory Affairs Specialist (Senior Level)
Pay : $38-$50/hr depending on experience
Shift : M-F, standard working hours. Hybrid role
Temp to hire
Overview:
We are seeking a Regulatory Affairs Specialist (Senior Level) to ensure company compliance with US FDA 510(k), Health Canada Licensing, International Device Submissions, Licensing and Registration requirements, ISO/FDA QSR, and ISO 13485. The role involves quality system auditing and more specific responsibilities as outlined below.
Responsibilities :
Lead and Support US 510(k) Submissions
Lead and Support Health Canada Device License Applications
Lead and Support International Device Licensing and Registrations
Support Product Development Teams for New Product Submission Requirements
Product Technical Files Development and Maintenance
Review and Approval of ECOs Related to Assigned Projects
Experience with EU MDD and EU MDR
Participate in Quality System Audits
Technical Writing and Documentation
Support UDI Labeling Projects
Managing and Driving All Aspects of International Regulatory Affairs from Creation to Submission of Technical Documentation (e.g., Technical Files, Design Dossiers, GSPRs for CE Marking) and Post-Market Follow-Ups
Support FDA Regulatory Requirements with Creation, Reviewing, Editing, Assembling, and Submission of Documentation (e.g., 510(k)s, Pre-subs, IDEs, PMAs, etc.)
Oversee Strategy Implementation and Operations for Developing Product Registration Submissions, Progress Reports, Supplements, Amendments, or Periodic Experience Reports
Interact with Regulatory Agencies to Expedite Submissions and Approvals
Monitor Regulatory Outcomes of Initial Product Concepts and Provide Input to Senior Regulatory Management
Collaborate with Clinical Operations to Ensure Clinical Study Results and Reports are Suitable for Regulatory Submissions
Responsible for Adverse Event (Vigilance, MDR) Reporting and Assessment, Evaluation of Product Complaints, and AE Report Compliance
Establish and Maintain Procedures Relating to MDR/CE Marking Processes in Accordance with MDCG, ISO, and Other Regulatory Requirements
Serve as Regulatory Liaison Throughout Product Development Lifecycle
Participate in Product Plan Development, Regulatory Strategy, Product Labeling, Risk Management, Post-Market Surveillance, and Post-Market Follow-Up
Ensure Alignment of Regulatory Strategy to Business Strategy Across All Functional Areas
Serve as a Regulatory Representative to Marketing, Clinical, Research Teams, and Regulatory Agencies
Ensure Regulatory Submissions and Technical Documentation Meet Standards and Content Requirements
Advise Development and/or Marketing Teams on Product Changes, Line Extensions, Technical Labeling, Regulations, and Interpretations
Write Regulatory Justifications to Support Design Changes and Submission Filing Decisions
Requirements:
Bachelor’s degree
5+ years of experience with EU MDD and EU MDR
5+ years of experience with 510(k) submissions
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As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Science & Clinical?
Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.
About Kelly
Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.
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