Sr Manager, Regulatory Affairs

Regulatory Strategy

• Providesleadership and expert guidance on current, new, and emerging regulations, standards, and guidanceapplicable to MergeHealthcare’sregulated and non-regulated enterprise imagingsolutions.

• Developsandmaintainsglobal regulatory strategiesregulatedmedical 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.

• Determinesregulatory requirements for new market entry, including product classification, applicable regulatory framework, local registration or licensing obligations, submission pathway, labelling or language requirements, in-country representationneeds, post-market obligations, and launch-readiness dependencies.

Regulatory Submissions & Communication

• Oversees global product registrations, establishmentlistingsor facility registrations where applicable, device licensing, certification, and market authorization activities forregulatedmedical devices and related imaging solutions, including entry requirements for new countriesorregions.

• Evaluatesnew products, software releases, patches, configuration changes, algorithm updates, cybersecurity updates, and other product modifications for regulatory impact todetermineglobal submission, notification, documentation, or market authorization requirements.

• Reviewslabeling, 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.

• Servesas primary liaison with regulatory authorities, notified bodies, and approved bodiesfor submissions,pre-submissions, deficiency responses, technical documentation reviews,adverse event reporting, recalls, inspections,and compliance matters.

• Drivestimelypreparation anddeliveryofregulatory submissions and market authorizations.

RegulatoryCompliance

• Monitorsregulatory changes and ensuretimelyimplementation across processes and products.

• PartnerswithQuality,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.

• Escalatesany significant risks, issues, or concerns affecting Merge Healthcare’s products, services, or business operations to executive leadership.

• Supportspost-market surveillance, vigilance reporting, complaint trend review, software anomaly assessment, cybersecurity vulnerability response, field action planning, and recall regulatory strategy forregulatedmedical devices and related imaging solutions.

• Drivescontinuous 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,andinspections.

Leadership & Team Development

• Leadsandmentora high-performing regulatory team, fostering collaboration and professional growth.

• Setsclear performance goals, providescoaching, and recognizesachievements.

Core Competencies

• Ability to work independently with minimal supervision in a team settingto meet definedobjectives.

• Ability to influence change and champion initiativestodrive 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 productdevelopment, andcommercial teams in a matrixed environment.

• Effective research and analytical skills.

• Effective written and oral communication, technicalwritingand 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 inpreparing andmaintainingmedical deviceand SaMDregulatory submissions, technical documentation, regulatory files, and market authorization packages forglobal regulatory authorities,includingUS FDA,HealthCanada, 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 devicesrequired; familiarity with AI/ML-enabled medical device guidance, predetermined change control expectations, and emerging global regulatory trends preferred.