Head of Regulatory Affairs - Radiology Informatics [Israel]

 

Job Title

Head of Regulatory Affairs - Radiology Informatics

Job Description

You will be an integral team member of the Enterprise Informatics Regulatory Affairs Leadership Team and therefore, influence and shape the regulatory capabilities for the future success of Philips. Moreover, you will be accountable for Regulatory Affairs input and deliverables to the Enterprise Informatics Regulatory Affairs Leadership Team. You will be responsible for the development and deployment of innovative, compliant regulatory strategies and obtaining/ maintaining product market access authorizations, to grow and sustain the Philips portfolio across Radiology Informatics. There are key opportunities to build regulatory capabilities to drive software and AI applications in combination with the product portfolio, as well as drive efficiencies through regulatory operations excellence.

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Your role:

• Leading 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, 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.
• Represent the regulatory affairs function at the Radiology Informatics Leadership Team.
• Lead and enable strong cross-functional partnerships 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.
• 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:

• Minimum of a Master’s degree (or equivalent), preferably in an Informatics or life-scientific field.
• Minimum of 10+ years of experience working in Regulatory Affairs within a medical device industry.
• Experience with software-enabled medical devices, SaMD, AI, digital health, cloud computing, and associated development methodologies as well as lifecycle topics.
• Minimum of 5+ years of functional management, and strategic leadership – with a strong track record in successfully leading a Regulatory Affairs team to bring products to market on time.
• Extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, IDE, 510(k), Technical Files/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.
• Experience with IDE and review of clinical dossiers for market access authorizations is a plus.
• Experienced in strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Competent Authorities).
• Experienced in formulating and implementing global regulatory strategies to ensure compliance with worldwide regulations to improve product market access.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.

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 commitment to diversity and inclusion here.

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