Global Regulatory Operations Analyst

Siemens Healthineers AG; 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 to support the Palo Alto, CA HQ. This role provides administrative and operational support to global and regional Regulatory Affairs teams, coordinating documentation and processes that underpin international product registrations.

You will manage CFG requests with the FDA, review submissions for completeness, maintain records, and assist with regulatory documentation, notarization, and shipment as

Qualifications

• Bachelor's degree in a related field is required.
• Some experience in medical device, life sciences, or related industry preferred.
• Regulatory operations experience is a plus.
• Proficiency with MS 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 activities.
• Review product information for completeness and accuracy per procedures.
• Track CFG requests and maintain supporting documentation.
• Coordinate and prepare routine regulatory documentation for product registrations.

Skills

Organizational skills

Attention to detail

Written and verbal communication

Independent and collaborative work

Education

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

Tools

Microsoft Word

Excel

Outlook

PowerPoint

Job description

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, coordinating documentation and processes that underpin international product registrations.

You will manage CFG requests with the FDA, review submissions for completeness, maintain records, and assist with regulatory documentation, notarization, and shipment as