Senior Manager Regulatory Affair

You will be part of the Regulatory Affairs team for AV business within Clinical informatics. Leading teams in regulatory strategy development in a dynamic business environment that ensure and maintain global market access of these products, directly impacts the lives of patients.
You will be an integral team member of a global Regulatory Affairs team for the AV business and therefore, influence and shape the regulatory capabilities for future success of Philips. 
Your role:

• Leading project teams for end-to-end regulatory affairs input and deliverables for new product introductions and product changes across the globe.
• Through end-to-end regulatory processes, ensuring safe and effective products / solutions are brought to market, on time, and sustained throughout life cycle via compliant, innovative regulatory strategies.
• Provide critical input on regulatory risk assessments to support portfolio selection.
• Collaborate and extend in proactive, strategic relationships with external stakeholders (Notified Bodies, FDA, Competent Authorities and other Regulatory bodies) to ensure that requirements are known early during strategy development, enabling rapid 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, Marketing, Quality, Clinical Affairs and other functions at all levels within the business, and the local Regulatory Affairs teams in the Philips international markets organization.
• Building FDA regulatory submissions strategy for the products portfolio, providing related guidance to cross functional dedicated team and authoring 510K submissions.

You're the right fit if you have:

• Bachelor's/Master’s degree, preferably in a life-scientific field.
• A minimum of 12 years of experience working in Regulatory Affairs
• At least 5 years of leading teams & people management.
• Practical knowledge and experience with SaMD (advanced Visualization for diagnosis support -significant advantage)
• Extensive knowledge and authoring of FDA and other regulatory submissions (Pre-submissions, 510(k), Technical Files/Design Dossier);
• Extensive knowledge of MDD, MDR, FDA SaMD related and cybersecurity guidances ,(ISO 13485, ISO 14971, IEC 62304)
• 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.

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
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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