Post Market Surveillance Analyst

Together, we can beat cancer.

At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions.

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

If you want to be part of this important mission, we want to hear from you. 

This position is part of the Varian’s Post Market surveillance (PMS) team supporting Varian’s ROS, MDO, and Brachy product lines. The Post Market Report Handler is a member of the post market surveillance team at Varian.

The role involves providing administrative support to the PMS engineering team and exercising judgment to solve problems. The ideal candidate should have prior professional experience working with senior level management both inside and outside the company and must have the ability to communicate effectively with customers, vendors, and competent authorities.

Responsibilities:

• Understanding post market documentation and following company standards and procedures for document control.
• Ensuring compliance through examination of records, reports, and operating practices.
• Working on projects that require data analysis.
• Maintaining and supporting PMS report data and metrics.
• Collecting and preparing information for submission to competent authority.
• Processing post market report submissions and coordinating responses to the competent authority.
• Staying up-to-date with industry trends and best practices, advising management on necessary actions.
• Processing and maintaining controlled documentation using proprietary software.
• Being flexible and responsive to multiple projects.
• Providing ongoing administrative support to the Senior Manager as needed.

Requirements:

• A Bachelor's degree in Engineering, Mathematics, Analytics, or a related science field.
• 2+ years of experience in Quality Systems/Regulatory in Medical Device Manufacturing with knowledge of GDP, CAPA, FSCA, FSN, complaint handling, incidents reporting, and submission.
• Experience in applying regulations and standards like FDA QSR, ISO 13485, EU MDR, and Health Canada.
• Proficiency in databases and Microsoft Office products.
• Strong interpersonal and communication skills, with a focus on customer service.
• Excellent writing skills with the ability to summarize information clearly and accurately.
• The ability to prioritize tasks, work in a fast-paced environment, learn quickly, work independently and as part of a team, and work well with employees of all levels.

Varian is required to comply with all local and applicable regulations that may be associated with vaccine requirements for certain roles.