[Remote] Regulatory Affairs Principal, NGS IVD

Note: The job is a remote job and is open to candidates in USA. Kelly Science & Clinical is seeking a Regulatory Affairs Principal for a 6-month contract-to-hire position with a leading biotechnology company. The role involves ensuring compliance of molecular diagnostic products with global regulatory frameworks and driving cross-functional engagement across teams for strategic submissions and regulatory compliance. Responsibilities • 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 • 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 • 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 • 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 • 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 • 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 • Deliver regulatory expertise in the review of project contracts, ensuring alignment with regulatory requirements for product development, manufacturing, and distribution • 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 Skills • Bachelor's degree with 12+ years, Master's degree with 8+ years, or PhD with 5+ years of relevant regulatory experience • Minimum of 6 years of direct regulatory experience in the medical device and/or diagnostics sector, spanning development, manufacturing, testing, and product distribution • Advanced degree (Master's or PhD) strongly 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 Company Overview • We’ve been helping organizations find the people they need longer than any other company in the world. It was founded in 1946, and is headquartered in Troy, Michigan, USA, with a workforce of 10001+ employees. Its website is Company H1B Sponsorship • Kelly has a track record of offering H1B sponsorships, with 85 in 2025, 76 in 2024, 59 in 2023, 74 in 2022, 81 in 2021, 65 in 2020. Please note that this does not guarantee sponsorship for this specific role. Apply tot his job