Global Regulatory Operations Analyst

Siemens Healthineers AG; Pao Pao; On-site; EUR 74,000 - 102,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term disability insurance

Short-term disability insurance

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

Siemens Healthineers is seeking a Regulatory Operations Analyst to support global and regional regulatory affairs. You will provide day-to-day administrative support, coordinate CFG requests with the FDA, and maintain documentation to enable international product registrations.

You will review submissions for completeness, track requests, prepare regulatory documents, and ensure timely communications across teams.

Qualifications

• Bachelor’s degree in a related field is required.
• Some experience in medical device, life sciences, or pharma preferred.
• Regulatory operations experience is a plus but not required.
• Proficiency in MS Office applications (Word, Excel, Outlook, PowerPoint).
• Strong organizational and communication skills; ability to work with global teams.

Responsibilities

• Provide day-to-day administrative and operational support to the regional Regulatory Affairs teams.
• Coordinate and process CFG requests through the FDA to support international product registrations.
• Review product information and supporting documentation for completeness and accuracy.
• Track CFG requests and maintain supporting documentation; learn applicable FDA requirements.
• Process requests via the Regulatory Operations Ticket System and follow up as needed.
• Coordinate and prepare routine regulatory documentation to support product registrations.
• Facilitate document execution, signatures, notarization, and legalization activities.
• Maintain accurate ticket statuses and communicate updates to global teams.
• Support reporting and metrics for workflow management and efficiency.

Skills

Microsoft Word

Microsoft Excel

Microsoft Outlook

PowerPoint

Organizational skills

Written and verbal communication

Education

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

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

PowerPoint

Job description

Siemens Healthineers is seeking a Regulatory Operations Analyst to support global and regional regulatory affairs. You will provide day-to-day administrative support, coordinate CFG requests with the FDA, and maintain documentation to enable international product registrations.

You will review submissions for completeness, track requests, prepare regulatory documents, and ensure timely communications across teams.