Regulatory Operations Analyst

• 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.