Regulatory Operations Manager Siemens Healthineers - 3.8 Palo Alto, CA Job Details Full-time $129,900 - $178,618 a year 1 day ago Benefits Disability insurance Health insurance Dental insurance 401(k) Paid time off Vision insurance Life insurance Qualifications Project management experience in technology ISO standards Bachelor's degree Project management experience in healthcare Leading team collaboration initiatives Biomedical regulatory compliance Cross-functional team management Cross-functional communication FDA regulations Full Job Description Join 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 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 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 Engagement Plan 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 Qualifications Bachelor'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. #LS-OS1 Who we are : We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual's potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world's most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. To find out more about Siemens Healthineers businesses, please visit our company page here. The base pay range for this position is: $129,900 - $178,618 Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate. If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance. The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan. life insurance, long-term and short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time.

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