Regulatory Operations Analyst

Regulatory Operations ManagerJoin us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.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 ResponsibilitiesRegulatory Operations Leadership & Market Access GovernanceManage 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 supportOversee 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 ImprovementLead 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 EngagementPerform regulatory reviews of sales bulletins, customer service communications, and promotional content to ensure alignment with approved regulatory clearances.Provide regulatory guidance to Quality, Legal, Engineering, Commercial, and Marketing teams regarding Regulatory Operations requirements and compliance considerations.Promote consistent application of regulatory operations requirements across global business activities.Regulatory Inspections & Agency EngagementPlan and coordinate site regulatory audit and inspection activities conducted by FDA, Health Canada, EU Notified Bodies, and global regulatory authorities, including preparation, logistics, documentation, and cross-functional readiness.Coordinate inspection responses, follow-up activities, and corrective and preventive actions (CAPA) resulting from audits and inspections.Support communications and meetings with regulatory agencies and industry organizations on regulatory operations matters.Perform other related duties and lead special projects as assigned to support Regulatory Affairs Operations and business objectives.Minimum QualificationsBachelor's degree in biomedical engineering, Regulatory, Business or a related field (master's degree preferred).5+ years of experience in Regulatory Operations or related functions within the medical device industry.Experience leading cross-functional initiatives and driving regulatory process improvements.Strong project management, organizational, and communication skills, with the ability to manage priorities and drive cross-functional initiatives to completion.Strong knowledge of global medical device regulatory requirements and standards, including FDA QMSR (21 CFR Part 820), ISO 13485, EU MDR (Regulation (EU) 2017/745), Canadian Medical Devices Regulations (SOR/98-282), and MDSAP.