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
Requirements: Bachelors degree (or equivalent), preferably in Informatics, engineering or life-sciences
A minimum of 10+ years of experience working in Regulatory Affairs within a medical device company
industry.
Experience with software enabled medical devices, SaMD, AI, digital health, cloud computing and associated development methodologies as well as lifecycle topics
Experience with radiology software devices with mature install base preferred
Ability to work collaboratively with cross functional team and leadership to arrive at decisions
Extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), Technical Files/Design Dossier)
Experience utilizing global regulatory policies, guidance and standards including FDA and EU
MDR expectation for radiology devices, QMS standards, safety risk management, software
development lifecycle, cybersecurity and labeling
Experience with AI / ML enable device authorizations preferably in radiology settings
This position is open to all candidates.