Director, Regulatory Affairs- Software and Artificial Intelligence (Ultrasound)

The Director, Regulatory Affairs-SW and AI will lead the regulatory strategy of all Software/Artificial Intelligence platforms for the Ultrasound business.

Your role:

• Lead a global Regulatory Affairs team for end-to-end regulatory affairs input and deliverables for regulatory strategy development of new product introductions, maintaining clearances and product changes across the globe. Through end-to-end regulatory processes, ensure safe and effective products/solutions are brought to market, on time, and sustained throughout the life cycle via compliant, innovative regulatory strategies. Provide critical input on regulatory risk assessments to support portfolio selection.
• Build proactive, strategic relationships with external stakeholders (notified Bodies, U.S. 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. Advise the regulatory and cross functional teams on the best communication and resolution strategies to address issues raised by government authorities during product reviews or audits
• Represent the regulatory affairs function within the Ultrasound Leadership Team.
• Lead and enable strong cross-functional partnerships between Regulatory Affairs and all key stakeholders including R&D, Product Management, Quality, Medical & Clinical Affairs, and other functions at all levels within the business, and the local Regulatory Affairs teams in the Philips market organization.
• Responsible for the hiring and development of critical talent within the global regulatory affairs team through creating and sustaining robust development plans, ongoing coaching, and feedback, and identifying and addressing capabilities gaps.

You're the right fit if:

• You’ve acquired 10+ years of experience working in Regulatory Affairs within the medical device industry; Experience with software-enabled medical devices, SaMD, AI, digital health, cloud computing, and associated development methodologies as well as lifecycle topics.
• You’ve acquired 5+ years of regulatory strategic leadership- with a strong track record in successfully leading a Regulatory Affairs team to bring products to market on time.
• Your skills include extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), Technical Documentations/Design Dossier); Knowledge of MDD, MDR, MedDev & MDCG’s, QMS standards, safety risk management, software development, cybersecurity and labeling standards, and other applicable regulations, standards, and application of them.
• You have a bachelor’s degree or higher, in an Informatics or Engineering field preferred.
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
• You’re experienced in strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Competent Authorities); Experience in formulating and implementing global regulatory strategies to ensure compliance with worldwide regulations to improve product market access.