Global Regulatory Operations Analyst: CFGs & Documentation

Regulatory Jobs; Palo Alto (CA); 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 and safe time

Job summary

Varian Medical Systems, a Siemens Healthineers company, is hiring a Regulatory Operations Analyst in Palo Alto, CA. You will support regional regulatory teams, coordinate CFG requests through the FDA, and maintain comprehensive regulatory records to enable international registrations.

The role emphasizes attention to detail, multi-tasking, and collaboration across global teams, with a base pay range disclosed and a full benefits package outlined for eligible employees.

Qualifications

• Bachelor's degree in a related field is required.
• Prior regulatory operations experience is a plus but not required.
• Strong skills in 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 registration.
• Review product information for completeness and accuracy per procedures.
• Track CFG requests and maintain regulatory documentation and records.
• Process requests via the Regulatory Operations Ticket System and follow up as needed.
• Prepare routine regulatory documentation to support product registrations.
• Facilitate document execution, notarization, apostille, and shipment as required.
• Maintain ticket statuses and report on workflow metrics.

Skills

Regulatory operations

Documentation management

Microsoft Office

Education

Bachelor's degree in Business Administration or Life Sciences

Job description

Varian Medical Systems, a Siemens Healthineers company, is hiring a Regulatory Operations Analyst in Palo Alto, CA. You will support regional regulatory teams, coordinate CFG requests through the FDA, and maintain comprehensive regulatory records to enable international registrations.

The role emphasizes attention to detail, multi-tasking, and collaboration across global teams, with a base pay range disclosed and a full benefits package outlined for eligible employees.