Regulatory Affairs Expert
Exciting opportunity to be part of Philips 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 Philips market organization. • Mentor and develop regulatory talent and competency to ensure strategic engagement and execution excellence
Qualifications: • Bachelor’s 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
How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
About Philips
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our culture of impact with care here.
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