Sr Manager, Regulatory Affairs

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.

Regulatory Compliance

• Monitors regulatory changes and ensure 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.

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.

Core Competencies

• Ability to work independently with minimal supervision in a team setting to meet defined objectives.

• Ability to influence change and champion initiatives to drive change in the organization.

• Excellent interpersonal, communication, and collaboration skills.

• Demonstrated ability to make risk-based regulatory decisions, communicate complex regulatory positions to executive and cross-functional stakeholders, and influence product development, and commercial teams in a matrixed environment.

• Effective research and analytical skills.

• Effective written and oral communication, technical writing and editing skills.

Technical Skills

• In-depth understanding of global medical device and SaMD regulatory frameworks, including FDA QSR/QMSR, ISO13485, Medical Device Single Audit Program (MDSAP), Canadian Medical Devices Regulations, EU MDR, UK medical device requirements, and other applicable international requirements.

• Proficient in preparing and maintaining medical device and SaMD regulatory submissions, technical documentation, regulatory files, and market authorization packages for global regulatory authorities, including US FDA, Health Canada, EU, and other applicable markets.

• Demonstrated ability to research, interpret, and document regulatory requirements for new market entry, including jurisdiction-specific classification, registration, conformity assessment, local representative, labelling, language, cybersecurity, privacy, and post-market obligations.

• Specific experience with SaMD/software medical devices, including working knowledge of software lifecycle, risk management, usability, clinical/performance evaluation, and cybersecurity expectations under applicable standards and guidance such as IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, and applicable regulatory guidance.

• Experience with cybersecurity expectations for connected software medical devices required; familiarity with AI/ML-enabled medical device guidance, predetermined change control expectations, and emerging global regulatory trends preferred.