Regulatory Affairs Principal, IVD Job Listing at Kelly Services in Sunnyvale, CA (Job ID US3564966_BH9841104)

Description

Kelly® Science & Clinical is currently recruiting a Regulatory Affairs Principal for an 18-month contract opportunity with a leading molecular diagnostics company at their Sunnyvale, CA location. 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: Remote (USA)
Position Title: Regulatory Affairs Principal, New Product Development
Pay rate: $60-63/hour  
Company: Kelly® Science & Clinical


Overview:
The Regulatory Affairs Principal serves as the RA lead on New Product Development (NPD) core teams working on medium to complicated assay, instrument, software projects and/or system projects. This individual prepares the regulatory submissions and interacts cross-functionally to ensure on-time delivery (OTD) of product launches. This role offers exposure to diverse products and projects, DBS tools to implement continuous improvement, and drives introduction of new product availability while enhancing career growth within Regulatory Affairs.


Responsibilities:

• Regulatory Submissions: Prepare and manage regulatory submissions for US and EU IVDR and WHO PQ, ensuring compliance and timely delivery for product launches.
• Agency Interaction: Communicate with regulatory agencies and health authorities to address queries and secure product approvals.
• Regulation Interpretation: Act as a representative to gather and interpret new regulations and guidelines affecting US and EU markets.
• Continuous Improvement: Utilize DBS tools to enhance processes and achieve efficiencies within the regulatory domain.
• Report and Presentation Preparation: Prepare formal reports and presentations to communicate strategies and project statuses effectively.

Essential Requirements:

• Education: Bachelor's degree with 8+ years of relevant experience. Master's degree with 6+ years of relevant experience. Doctoral degree with 3+ years of relevant experience.

• Project Leadership: Serve as RA lead on NPD core teams for complex assay, instrument, or software projects.
• Regulatory Strategy Development: Utilize extensive experience and intelligence to develop comprehensive regulatory strategies for initial product launches (US, EU, WHO/PQ).
• Documentation: Competency in compiling, preparing, reviewing, and submitting diverse regulatory submissions, including FDA pre-submissions, 510(k), and PMA submissions.

Preferred Qualifications

• CLIA waiver experinece is a plus.

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 is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly 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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