Regulatory Affairs Expert

Exciting opportunity to be part of Imaging Informatics regulatory team. Imaging Informatics
business unit includes solutions for radiology and cardiology. From enterprise imaging, PACS, and
workflow orchestration, through to a full suite of solutions for the cardiovascular workflow, we deliver
optimized imaging service lines that enable enterprise imaging across sites, specialties and technologies
to simplify medical image management, enable effective collaboration and enhance patient care. This role
will focus on radiology regulatory activities.

Responsibilities:
Represent regulatory affairs at the Radiology Informatics leadership team
Through end-to-end regulatory processes, ensuring safe and effective products are brought to
market, on time, and sustained throughout life cycle via compliant, innovative regulatory
strategies
Manage day-to-day functioning of radiology regulatory team ensuring effective and efficient
execution
Provide critical input on regulatory risk assessments to support portfolio selection and post
market decision making
Build proactive, strategic relationships with external stakeholders (Notified Bodies, FDA,
Competent Authorities, etc.) to ensure that requirements are known early during strategy
development, which enables fast market access with the current portfolio in connection with
future innovations.
Lead and enable strong cross-functional partnership between regulatory affairs and all key
stakeholders including R&D, Product Management, Quality, Clinical Affairs, and other functions at
all levels within the business, and the local Regulatory Affairs teams in the market
organization.
Mentor and develop regulatory talent and competency to ensure strategic engagement and
execution excellence