Sr Manager, Regulatory Affairs
MerativeAbout the role
Merge medical imaging solutions, offered by Merative, combine intelligent, scalable imaging workflow tools with deep and broad expertise to help healthcare organizations improve their confidence in patient outcomes and optimize care delivery
Leads global regulatory strategy and compliance for Merge Healthcare’s medical imaging portfolio, including Software as a Medical Device (SaMD), and related regulated and non-regulated healthcare technology solutions. This senior leadership role drives regulatory excellence across the software product lifecycle, including device classification, regulatory strategies for market access, design change assessment, cybersecurity considerations, post-market obligations, and alignment with international regulations, standards, and guidance. The Sr Manager, Regulatory Affairs provides strategic guidance, fosters cross-functional collaboration, and mentors a high-performing team to achieve business objectives while maintaining regulatory compliance.
Regulatory Strategy
Provides leadership and expert guidance on current, new, and emerging regulations, standards, and guidance applicable to Merge Healthcare’s regulated and non-regulated enterprise imaging solutions.
Develops and maintains global regulatory strategies regulated medical devices and related imaging solutions, including device classification, intended use and indications alignment, regulatory pathway selection, submission strategy, conformity assessment planning, and market authorization approach.
Determines regulatory requirements for new market entry, including product classification, applicable regulatory framework, local registration or licensing obligations, submission pathway, labelling or language requirements, in-country representation needs, post-market obligations, and launch-readiness dependencies.
Regulatory Submissions & Communication
Oversees global product registrations, establishment listings or facility registrations where applicable, device licensing, certification, and market authorization activities for regulated medical devices and related imaging solutions, including entry requirements for new countries or regions.
Evaluates new products, software releases, patches, configuration changes, algorithm updates, cybersecurity updates, and other product modifications for regulatory impact to determine global submission, notification, documentation, or market authorization requirements.
Reviews labeling, instructions for use, release notes, customer communications, promotional materials, interoperability statements, cybersecurity statements, and AI/automation claims for consistency with cleared or authorized intended use and applicable global regulations.
Serves as primary liaison with regulatory authorities, notified bodies, and approved bodies for submissions, pre-submissions, deficiency responses, technical documentation reviews, adverse event reporting, recalls, inspections, and compliance matters.
Drives timely preparation and delivery of regulatory submissions and market authorizations.
Regula
Apply for this role
Generate a tailored application kit with a matched cover letter, interview prep, and CV highlights — in under 60 seconds.
Apply Now →Generate Application KitFree account required — sign up in 30s