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 for regulated medical devices and related imaging solutions, including device classification, intended use alignment, and submission strategy.

Regulatory Submissions & Communication:

• Oversees global product registrations, establishment listings, device licensing, certification, and market authorization activities for regulated medical devices.
• Serves as primary liaison with regulatory authorities, notified bodies, and approved bodies for submissions, pre-submissions, deficiency responses, and compliance matters.

Regulatory Compliance:

• Monitors regulatory changes and ensures timely implementation across processes and products.
• Supports post-market surveillance, vigilance reporting, complaint trend review, and cybersecurity vulnerability response.

Leadership & Team Development:

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