Regulatory Operations Manager

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Varian Medical Systems, a Siemens Healthineers company is hiring a Regulatory Operations Manager to support the Palo Alto, CA HQ.

The Regulatory Operations Manager leads global regulatory operations to support market access, regulatory requirements, and operational effectiveness for Varian and its medical device portfolio.

This role manages a Regulatory Operations team, oversees global market clearance governance, regulatory systems, regulatory data, inspection readiness, and process improvement initiatives while partnering with cross-functional teams to ensure compliance with FDA, Health Canada, EU, and other international regulatory requirements.

Key Responsibilities

Regulatory Operations Leadership & Market Access Governance


* Manage and develop a team of three Regulatory Operations professionals supporting global regulatory operations, fostering collaboration and setting clear objectives.


* Govern global market clearance status and maintain regulatory product lifecycle information in regulatory systems, including new product introductions and phase-out activities, ensuring accurate regulatory records and market status to support product availability.


* Oversee regulatory operations workflows, including documentation requests, facility registrations, establishment renewals and product registration support


* Oversee the regulatory ticket system, ensuring requests are appropriately prioritized, assigned, tracked, and resolved in a timely manner.


* Provide guidance and training on regulatory operations processes, tools, and requirements.


* Oversee UDI (Unique Device Identification) data management activities to ensure accuracy, consistency, and compliance with applicable regulatory requirements across global markets.


* Serve as an escalation point for complex regulatory operations issues, working with cross-functional stakeholders to support timely resolution and practical problem-solving.

Regulatory Systems, Digitalization & Continuous Improvement


* Lead regulatory digitalization initiatives, including dashboards, reporting tools, and centralized systems that improve visibility of global regulatory status.


* Develop and implement standardized workflows and data-driven solutions to enhance transparency, efficiency, and process effectiveness.


* Maintain and improve Regulatory Operations procedures, work instructions, templates, and training materials.

Regulatory Support & Cross-Functional Engagement


* Perform regulatory reviews of sales bulletins, customer service communications, and promotional content to ensure a...