Sr Manager, Regulatory Affairs
Leadership & Team Development
Leads and mentor a high-performing regulatory team, fostering collaboration and professional growth. Sets clear performance goals, provides coaching, and recognizes achievements.
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.
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.
Regulatory Compliance
Maintains regulatory compliance by monitoring regulatory changes and ensuring timely implementation across processes and products. Partners with Quality, Product, Engineering, and Customer Support teams on compliance issues, complaints, CAPAs, field issues, and customer or regulatory inquiries to assess regulatory reporting, market action, and authority communication requirements. Escalates any significant risks, issues, or concerns affecting Merge Healthcare’s products, services, or business operations to executive leadership. Supports post-market surveillance, vigilance reporting, complaint trend review, software anomaly assessment, cybersecurity vulnerability response, field action planning, and recall regulatory strategy for regulated medical devices and related imaging solutions. Drives continuous improvement of regulatory and quality processes that support software development, design controls, risk management, verification and validation, release governance, technical documentation, internal audits, external audits, and inspections.