Regulatory Operations Manager

Siemens Healthineers; Berlin; Vor Ort; EUR 112.000 - 154.000; Vollzeit

Benefits dieser Stelle

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Zusammenfassung

Siemens Healthineers, via Varian Medical Systems, seeks a Regulatory Operations Manager to lead global regulatory operations supporting market access and compliance for the medical device portfolio. The role focuses on governance, systems, data, and cross-functional collaboration to ensure regulatory readiness.

Responsibilities include managing a small team, overseeing registration activities, and driving process improvements in a complex, multinational environment with FDA, EU MDR, and other

Qualifikationen

• Bachelor’s degree in biomedical engineering, Regulatory, Business or a related field (master’s degree preferred).
• 5+ years of experience in Regulatory Operations within the medical device industry.
• Experience leading cross-functional initiatives and driving regulatory process improvements.

Aufgaben

• Lead global regulatory operations to support market access and compliance.
• Manage regulatory systems, documentation requests, registrations, and CAPA follow-up.
• Oversee UDI data management and registration governance across markets.
• Coordinate regulatory inspections and serve as escalation point for issues.
• Provide training and guidance on regulatory processes to global teams.

Kenntnisse

Regulatory Operations

Project Management

Cross-functional Leadership

Regulatory Knowledge

Communication Skills

Ausbildung

Bachelor's degree

Master's degree preferred

Jobbeschreibung

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.

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.

Equal Employment Opportunity Statement:

Siemens Healthineers is an Equal Opportunity and Aff… encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

EEO is the Law:

Applicants and employees are protected under Federal law from discrimination. To learn more, click here.

Reasonable Accommodations:

Siemens Healthineers is committed to equal employment opportunity. As part of this commitment, we will ensure that persons with disabilities are provided reasonable accommodations.

If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at [e-mail]. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

California Privacy Notice:

California residents have the right to receive additional notices about their personal information. To learn more, click here.

Export Control:

A successful candidate must be able to work with controlled technology in accordance with US export control law. It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.

Data Privacy:

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Register here to get started.

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 disability insurance
• short-term disability insurance
• paid parking/public transportation
• paid time off
• paid sick and safe time