Regulatory Affairs Principal, NGS IVD

Kelly® Science & Clinical is seeking a Regulatory Affairs Principal for a 6-month contract-to-hire position with one of our clients, a leading commercial-stage immune medicine biotechnology company in Seattle. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts. Workplace: Remote (US Pacific Time) Pay: $55-80 per hour Position title: Regulatory Affairs Principal, NGS IVD Position type: Contract-to-hire Overview The Regulatory Affairs Principal will serve as a key leader within the organization, ensuring the development, commercialization, and ongoing operation of molecular diagnostic products are fully compliant with global regulatory frameworks, including FDA, CLIA, CAP, IVDR, and other applicable international standards. This highly visible role will drive cross-functional engagement across regulatory, quality, and business teams, collaborating closely on strategic submissions, regulatory compliance, and direct interactions with regulatory authorities and key external partners. Responsibilities and • Lead & Oversee Regulatory Submissions: Guide and authorize global regulatory filings for new product launches, expanded indications, and significant product changes. Provide expert counsel on regulatory strategy and documentation requirements, ensuring timely and robust submissions in alignment with business objectives. • Global Regulatory Leadership: Direct regulatory submission processes in key international jurisdictions—including the EU, APAC, and Australia—while taking primary accountability for compliance under IVDR and other region-specific frameworks. • Change Management & Notification Strategy: Design and execute global change notification strategies for modifications to registered products. Safeguard regulatory adherence and ensure seamless implementation in alignment with U.S. and international standards. • Regulatory Communications & Risk Management: Represent the organization in communications with regulatory authorities, notably in the context of notifiable nonconformances, adverse events, and post-market issues. Ensure prompt and responsible disclosure and response management. • Ownership of Regulatory Processes: Champion best practices for regulatory documentation, process development, and continuous improvement initiatives across the regulatory affairs landscape. Maintain and evolve regulatory records and SOPs to reflect current industry and agency requirements. • Quality & Regulatory Integration: Partner with quality system owners to interpret regulatory requirements, identify compliance gaps, and develop robust mitigation strategies. Ensure all systems and processes meet current and emerging regulatory standards. • Contract Review & Regulatory Guidance: Deliver regulatory expertise in the review of project contracts, ensuring alignment with regulatory requirements for product development, manufacturing, and distribution. • Continuous Compliance Monitoring: Keep cross-functional teams informed of new or evolving regulatory standards, expanded claims, recalls, and adverse event updates. Support annual post-launch monitoring and reporting, ensuring timely submission of data-driven insights for ongoing compliance. Qualifications Required: • Bachelor’s degree with 12+ years, Master’s degree with 8+ years, or PhD with 5+ years of relevant regulatory experience. • Advanced degree (Master’s or PhD) strongly preferred. • Minimum of 6 years of direct regulatory experience in the medical device and/or diagnostics sector, spanning development, manufacturing, testing, and product distribution. Preferred: • Proven leadership in managing regulatory submissions with the FDA, EMA, and other major ex-US regulatory bodies. • Demonstrated expertise in both U.S. and international IVD regulatory frameworks. • Comprehensive understanding of post-market surveillance regulations, best practices, and reporting procedures What happens next? Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless. #P1 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. 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. Apply tot his job