Sr Manager, Regulatory Affairs

Merative

1d•$144,633 - $216,949•Remote

About The Position

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.

Requirements

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.
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.
10+ years of experience in medical device regulatory affairs, healthcare technology, life sciences, or a similarly regulated industry, including significant experience supporting SaMD/software medical devices.
At least 8 years leading and managing teams in a medium-to-large organization in a regulated industry strongly preferred.
Demonstrated experience building and leading high-performing regulatory teams and programs by developing talent, strengthening succession plans, standardizing regulatory assessment processes, improving submission quality and timeliness, and representing Regulatory Affairs in portfolio and release governance.
Bachelor’s degree in a scientific or technical discipline required, or equivalent experience.
Proven experience (10+ years) in medical device regulatory affairs, healthcare technology, life sciences, or similar regulated industries, with direct experience supporting Software as a Medical Device (SaMD), software used with medical devices, or regulated healthcare software.
At least 5 years’ leadership or management experience in a medium to large-sized organization.
Experience leading interactions with global regulatory authorities, notified bodies, and approved bodies, including pre-submissions, deficiency responses, technical documentation reviews, market authorization maintenance, inspections, and regulatory commitments.

Nice To Haves

Professional medical device certification preferred, such as Regulatory Affairs Certification (RAC).
Familiarity with AI/ML-enabled medical device guidance, predetermined change control expectations, and emerging global regulatory trends preferred.

Responsibilities

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.
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.
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.
Leads and mentor a high-performing regulatory team, fostering collaboration and professional growth.
Sets clear performance goals, provides coaching, and recognizes achievements.