Regulatory Operations Analyst

Siemens Healthineers AG; Berlin; On-site; EUR 74,000 - 101,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Disability insurance

Paid parking

Paid time off

Paid sick time

Job summary

Varian Medical Systems, a Siemens Healthineers company, is hiring a Regulatory Operations Analyst to support global and regional Regulatory Affairs. You will provide administrative and operational support, coordinating documentation and CFG requests with FDA to aid international product registrations.

The ideal candidate has a bachelor’s degree, strong organizational skills, and proficiency in MS Office. Responsibilities include maintaining records, processing requests through the ticket system,

Qualifications

• Bachelor's degree in a relevant field is required.
• Some experience in medical device, life sciences, or related industry preferred.
• Regulatory Operations experience is a plus but not required.
• Proficiency in MS Word, Excel, Outlook and PowerPoint.
• Strong organization, attention to detail and communication skills.

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 and documentation for completeness and accuracy.
• Track CFG requests and maintain supporting documentation.
• Process requests via the Regulatory Operations Ticket System and follow up as needed.
• Prepare routine regulatory documentation to support global/regional product registrations.
• Facilitate document execution and authentication, including signatures and notarization.
• Maintain ticket statuses and communicate updates to Regulatory Affairs teams.
• Support ticket tracking, reporting, and operational metrics.
• Follow Regulatory Operations procedures and templates.
• Obtain a California Notary Public commission and perform mobile notarization as needed.

Skills

Regulatory operations

Documentation management

Notary coordination

Multi-tasking

Communication

Education

Bachelor's degree in Business Administration, Legal Administration, Public Administration, Life Sciences, or related field

Tools

Microsoft Word

Excel

Outlook

PowerPoint

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 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.

What You will do

• 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.

What You will have

• 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

#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:

$82,920 - $114,015

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

Equal Employment Opportunity Statement

Siemens Healthineers is an Equal Opportunity and Affiinitiative 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.

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Reasonable Accommodations

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“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.”

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