Regulatory Operations Analyst

Varian Medical Systems, a Siemens Healthineers company, is hiring a Regulatory Operations Analyst to support global and regional Regulatory Affairs teams. The role coordinates regulatory documentation and processes for international product registrations, including CFG requests, recordkeeping, document execution, and operational tracking.

What you'll 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 they're looking for:

• A bachelor's degree in Business Administration, Legal Administration, Public Administration, Life Sciences, or a related field
• 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
• A successful candidate must be able to work with controlled technology in accordance with US export control law
• Some experience in the medical device, life sciences, pharmaceutical, or a related industry
• Regulatory Operations experience

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