Regulatory Affairs Principal Job Listing at Kelly Services in Sunnyvale, CA (Job ID US3530532_BH9716085)

Description

Title: Regulatory Affairs Principal
Remote
Pay: 58-63/hr

Overview:
The Regulatory Affairs Principal plays a vital role as the Regulatory Affairs (RA) lead in New Product Development (NPD) core teams. This role focuses on medium to complex assay, instrument, software, and system projects. This position is part of the Global Regulatory Affairs department and can be based in Sunnyvale, CA or remote.

Key Responsibilities:

• Preparation and Submission: Prepare regulatory submissions and work cross-functionally to ensure on-time delivery (OTD) of product launches.
• Regulatory Interactions: Engage with regulatory agencies and health authorities to resolve inquiries and obtain product approvals, primarily focusing on US and EU In Vitro Diagnostic Regulation (IVDR) and WHO Prequalification (PQ) submissions.
• Guidance and Compliance: Provide guidance on safety and regulatory matters throughout the design, manufacturing, and inspection processes, ensuring compliance with international market standards.
• Regulatory Monitoring: Act as the representative to gather and interpret new and updated regulations and guidelines in the US and EU.
• Continuous Improvement: Implement continuous improvement initiatives and efficiencies using DBS tools.

Requirements: Educational Background:

• Bachelor's degree with 8+ years of related work experience
• Master's degree with 6+ years of related work experience
• Doctoral degree with 3+ years of related work experience

Technical Expertise:

• Serve as RA lead on NPD core teams involving medium to complicated assay, instrument, or software projects and submissions (510(k), De Novo).
• Possess a high level of technical understanding of hardware, software, wireless connectivity, and safety guidelines, including RoHS, REACH, and EMC testing requirements.
• Regulatory Strategy: Use extensive experience and regulatory intelligence to develop regulatory strategies for initial product launches (US, EU, WHO/PQ).
• Documentation: Author and prepare regulatory submissions (US-FDA, IVDR, WHO/PQ) as required by the project plan.
   

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 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.

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