Regulatory Affairs Principal, NGS IVD

Regulatory Affairs Principal

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. 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 Expertise

• 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 jurisdictionsincluding the EU, APAC, and Australiawhile 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.

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.