Regulatory Operations Analyst

591x Varian Medical Systems, Inc.; United States; On-site; USD 83,000 - 114,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking/public transportation

Paid time off

Paid sick time

Job summary

Varian Medical Systems, a Siemens Healthineers company, is seeking a Regulatory Operations Analyst to support the Palo Alto, CA HQ. You will provide administrative and operational support to global and regional Regulatory Affairs teams and coordinate documentation for international product registrations.

The role requires a bachelor’s degree and strong MS Office skills, with the ability to manage multiple requests and collaborate across teams while ensuring compliance with FDA requirements.

Qualifications

• Bachelor’s degree in Business Administration, Legal Administration, Public Administration, Life Sciences, or a related field is required.
• Some experience in medical device, life sciences, pharmaceutical, or related industry preferred.
• Proficiency in Microsoft Word, Excel, Outlook, and PowerPoint.

Responsibilities

• Provide day-to-day administrative and operational support to regional Regulatory Affairs teams.
• Coordinate and process CFG requests through the FDA to support international product registrations.
• Review product information for completeness and accuracy per procedures.
• Track CFG requests and maintain supporting documentation and regulatory knowledge.
• Prepare regulatory documentation to support global and regional registrations.

Skills

MS Office

Organizational skills

Communication

Multitasking

Detail-oriented

Education

Bachelor’s degree (Business Admin, Legal Admin, Public Admin, Life Sciences etc.)

Job description

Regulatory Operations Analyst – Palo Alto, CA

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 Analyst to support the Palo Alto, CA HQ. This role provides administrative and operational support to global and regional Regulatory Affairs teams, helping coordinate documentation and processes that support international product registrations. The position is ideal for a detail-oriented professional who can manage multiple requests, maintain accurate records, and collaborate effectively across teams.

Responsibilities

• Provide day-to-day administrative and operational support to the regional Regulatory Affairs teams.
• Coordinate and process Certificate to Foreign Government (CFG) requests through the FDA to support international product registration activities.
• Review product information and supporting documentation for completeness and accuracy in accordance with established procedures.
• Track CFG requests, maintain supporting documentation, and develop working knowledge of applicable FDA requirements and processes.
• Process requests submitted through the Regulatory Operations Ticket System, review submissions for completeness, and follow up with requestors as needed.
• Coordinate and prepare routine regulatory documentation, as needed, to support global and regional Regulatory Affairs teams with product registration activities.
• Facilitate document execution and authentication, including obtaining signatures and coordinating notarization, apostille/legalization, and shipment, as required.
• Maintain accurate ticket statuses, communicate updates to global Regulatory Affairs teams, and maintain complete records of requests and their resolution.
• Support ticket tracking, reporting, and operational metrics to facilitate workflow management and efficiency.
• Follow established Regulatory Operations procedures, work instructions, and templates.
• Obtain a California Notary Public commission upon hire and perform mobile notarization activities as needed.

Requirements

• A bachelor's degree in Business Administration, Legal Administration, Public Administration, Life Sciences, or a related field is required.
• Some experience in the medical device, life sciences, pharmaceutical, or a related industry preferred.
• Regulatory Operations experience is a plus but not required.
• Proficiency in Microsoft Word, Excel, Outlook, and PowerPoint.
• Strong organizational skills and attention to detail.
• Ability to prioritize multiple requests, manage competing deadlines, and maintain accurate documentation.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively with global and cross-functional teams.

Benefits

• 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

Base Pay Range

$82,920 - $114,015

Commission Eligibility

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.

Export Control Requirement

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.

Equal Employment Opportunity Statement

Siemens Healthineers is an Equal Opportunity and Affiantive Action Employer 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,

Company Information

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.

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously.

California Privacy Notice: California residents have the right to receive additional notices about their personal information.

We are a team of 72,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

Culture

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.