Senior Regulatory Affairs Manager- REMOTE

📋 Description

• • Own the North America regulatory strategy for Revvity’s entire in-vitro diagnostic portfolio, translating complex scientific breakthroughs into clear, compliant pathways that reach clinicians and patients faster.
• • Drive the end-to-end preparation, review, and submission of US 510(k), PMA, De Novo, and Health Canada applications for assays, instruments, and software—ensuring every technical file is audit-ready, scientifically rigorous, and delivered on aggressive timelines.
• • Act as the regulatory voice on cross-functional project teams (R&D, Quality, Clinical, Marketing, Manufacturing), providing real-time risk assessments and strategic guidance that keeps programs on schedule and within budget.
• • Continuously evaluate product changes, labeling updates, and manufacturing process modifications for regulatory impact; communicate findings to global Regulatory Affairs and project leadership so that no surprise derails a launch.
• • Partner with in-country dealers and international affiliates to secure market clearances across LATAM, APAC, and EMEA; supply dossiers, respond to agency questions, and shepherd renewals so Revvity’s innovations can improve health outcomes worldwide.
• • Maintain an always-current command of FDA, Health Canada, ICH, IVDR, and other evolving guidance documents; distill regulatory intelligence into actionable recommendations that shape product roadmaps and corporate policy.
• • Provide critical regulatory input on clinical study protocols and risk-management files, ensuring endpoints, statistics, and safety plans satisfy agency expectations and support robust claims.
• • Support CE-marking activities for IVD products manufactured in the US and abroad, collaborating with EU Authorized Representatives and Notified Bodies to maintain certificates and technical documentation under IVDR.
• • Review and approve promotional materials, IFUs, user manuals, and digital content to guarantee messaging is truthful, non-misleading, and fully compliant with FDA, FTC, and Health Canada advertising rules.
• • Manage import/export permitting, TSCA, and ITAR/EAR requirements for instruments, reagents, and software, eliminating customs delays and ensuring seamless global logistics.
• • Mentor junior regulatory associates and create scalable processes, templates, and training that raise the bar for quality and speed across the organization.
• • Represent Revvity in industry trade associations and standards committees, influencing future regulations while positioning the company as a thought leader in personalized diagnostics and precision medicine.