Regulatory Affairs Principal, Systems and Software Job Listing at Kelly Services in Sunnyvale, CA (Job ID US3537933_BH9741173)

Description

Kelly® Science & Clinical is seeking a Regulatory Affairs Principal for a 6-month contract opportunity with a leading molecular diagnostics company based in Sunnyvale, CA. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology realm.
Workplace: Onsite in Sunnyvale, CA or Remote US
Position Title: Regulatory Affairs Principal
Position Type: One-year contract
Pay rate: $58-63/ hour.
Company: Kelly® Science & Clinical
Overview
The Regulatory Affairs Principal serves as RA lead on New Product Development (NPD) core teams, working on medium to complicated assay, instrument, software projects and/or system projects. This position is part of the Global Regulatory Affairs department
Responsibilities

• Prepare regulatory submissions and interacts cross-functionally to ensure OTD of product launches.
• Interact with regulatory agencies/health authorities to resolve queries and to obtain product approvals with a focus on US and EU IVDR and WHO PQ submissions as required.
• Serves as representative to gather and interpret new and changed regulations and guidelines in US and EU.
• Implements continuous improvements and efficiencies using DBS tools.

Qualifications

• Bachelor's degree in field with 8+ years of related work experience OR Master's degree in field with 6+ years of related work experience OR Doctoral degree in field with 3+ years of related work experience Serves as RA lead on new product (NPD) core teams including medium to complicated assay, instrument or software projects and submissions (510(k), De Novo, Class A, B & C).
• Uses extensive experience and regulatory intelligence information and product knowledge to develop regulatory strategy for submissions that are in scope for the initial product launch (US, EU, WHO/PQ).
• Authors and prepare regulatory submissions (US-FDA, IVDR, WHO/PQ) as required by project plan.
• Prepares formal written reports, PowerPoint presentations to communicate regulatory strategies and status.

Preferred:

• Actively participating in project core teams, developing regulatory plans and collaboratively achieving project goals and meet timelines, experience with, software/hardware devices, or IVD products.
• Compiling, preparing, reviewing, and submitting regulatory submissions including FDA pre-submissions, 510(k) and PMA submissions Critical review of study protocols and reports to assess quality, clearly identify gaps, and provide mitigations

Why Join Us:

• Competitive compensation package and potential for permanent placement following the temporary period.
• Opportunity to work at the forefront of biotechnology innovation in a collaborative and dynamic environment.
• Access to ongoing career development and networking opportunities through Kelly® Science & Clinical's expansive network of industry experts and recruiters.

If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research.
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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 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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