Director of Regulatory Affairs - Software & Systems

Your role

• Responsible for Strategic Regulatory leadership and the development of regulatory strategies, detailed regulatory plans and submissions.
• Execute pre-market and post-market regulatory activities as per applicable procedures in I&S, IP&S and business units as assigned. This position will support software enabled medical devices with focus on major markets including the US and EU.
• Proactively provide clear regulatory inputs, guidance and deliverables for new product introductions and product changes.
• Provide clear and timely interpretation of global regulations that are actionable for assigned projects.
• Represent regulatory in key activities including Quality Management Reviews, risk management, design reviews, portfolio selection process, change management, adoptions of new guidance / standards, post-market activities, audits, inspections.
• Support audits, inspections, and surveillance visits by regulatory agencies and Notified Body as a regulatory representative.
• Actively participate in regulatory skill development and knowledge sharing.
• Reporting to the Head of Regulatory Affairs-Enterprise Informatics/Innovation & Strategy you will partner with stakeholders in the Innovation & Strategy (I&S), Intellectual Property & Standards (IP&S) as well as other Philips business units to gain global market authorization for software enabled solutions. You will Interact with internal/external stakeholders, including regulatory authorities/development partners and lead/enable strong cross-functional partnerships between Regulatory Affairs and all key stakeholders including R&D, Marketing, Quality, Clinical Affairs, and other functions.
• This Hybrid role may require travel up to 15%.

• You’ve acquired a minimum of minimum of 10 years’ experience in Regulatory Affairs within FDA regulated medical device/software (SaMD, SiMD) environments (required), with a minimum of 3 years’ experience in functional/strategic leadership.
• You have experience with regulatory requirements for AI, algorithms, data science, cloud computing and interoperability highly preferred. Experience with wearable medical devices-(ECG, PPG, or similar) highly desired.
• You’ve acquired extensive experience and knowledge of global medical device regulations, guidance, and applicable standards. Experience with FDA’s pre-submission and submissions (510(k) s, De Novo, 513(g) etc.), EU MDR process, Technical Documentation preparation and associated guidance, standards.
• You have expertise in software specific regulatory guidance, standards including (not limited to) software (IEC 62304/82304) / device lifecycle management, risk management (ISO 14971), cybersecurity, human factors (IEC 62366), clinical and bench top testing.
• You’re able to efficiently review typical device development artifacts, DHF documents and provide guidance / feedback to cross functional team to enable the development of safe, effective, and high-quality products.
• You have the ability to review clinical study plans, reports, and statistical analysis artifacts for use in device regulatory submissions.
• You have a proven track record of working effectively with cross-functional teams and working in a matrix organization (a plus).
• You’re well versed in methodologies (lean, agile) and associated tools for software development.
• You acquired extensive experience in managing strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities, development partners).
• You have a minimum of a Master's degree (Required) in Engineering, Regulatory Affairs, Life Sciences or similar disciplines.
• You’re able to communicate, influence and build relationships with Internal/External Stakeholders at all levels.
• You must be able to successfully…