Scientist, IVD Product Development Job Listing at Kelly Services in Raleigh, NC (Job ID US3608370_BH9910757)

Description

Job Title: Scientist, IVD Product Development

Position Summary:
We are seeking a Scientist to lead the development of new in-vitro diagnostic (IVD) products within a CLIA-accredited clinical diagnostic laboratory. The ideal candidate will bring a strong scientific foundation, hands-on laboratory expertise, and a drive for innovation. This full-time, exempt, onsite position requires a comprehensive understanding of regulatory requirements, quality systems, and the full IVD product development lifecycle—from research and development through testing and manufacturing. The position reports to senior leadership in Quality & Regulatory.

Key Responsibilities:

• Collaborate with research and clinical laboratory teams to develop IVD products for regulatory submissions and global market clearance.

• Draft and maintain product requirement documents and risk management files.

• Manage and update design history files in alignment with regulatory standards.

• Coordinate with external vendors and suppliers for procurement of IVD product kits and components.

• Drive the development of new products through all phases, ensuring regulatory readiness.

• Design, implement, and oversee verification and validation (V&V) testing protocols, including documentation and resolution of any issues.

• Analyze data and produce technical reports suitable for regulatory submission and review.

• Troubleshoot product or process issues and contribute to continuous improvement initiatives.

• Stay informed on scientific and technological developments relevant to IVD product development.

• Perform other related duties as assigned.

Qualifications:

• Bachelor's or Master's degree in biology, microbiology, immunology, chemistry, biochemistry, clinical laboratory science, or a related discipline.

• Minimum of 4 years of relevant industry experience, including familiarity with CLIA laboratory operations.

• Direct experience in developing IVD products that have received FDA approval or clearance.

• Working knowledge of ISO 13485 quality management systems.

• Familiarity with regulatory frameworks, including CLIA, FDA (510(k), PMA), IVDR, ISO 13485, and CLSI standards.

• Experience with BSL-2 and enhanced BSL-2 procedures for biological sample handling.

• Proficient with Microsoft Office tools, especially Excel.

• Strong written and verbal communication skills, with the ability to convey technical concepts to diverse audiences.

• Excellent analytical thinking, attention to detail, and problem-solving skills.

• Ability to manage multiple projects in a fast-paced setting.

• Capable of working both independently and collaboratively.

• Self-driven and committed to fostering a positive and productive team environment.

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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