Regulatory Affairs Manager MS&S (all genders)

Your Role

You are a People Manager based in Böblingen within the Hospital Patient Management (HPM) Regulatory organization, focusing on Monitoring Platforms and Solutions for vital signs monitoring.

You act as a strategic Regulatory leader and Subject Matter Expert (SME) at a junior management level. You lead regulatory SMEs, interpret regulatory requirements for monitoring platforms, and work closely with Regulatory Affairs Specialists to ensure compliant implementation into products and software releases.

You provide regulatory guidance and training on U.S., European, and global requirements, oversee regulatory submissions (including U.S. 510(k)), and collaborate closely with R&D, Quality, Marketing, and global Regulatory teams throughout the product lifecycle to ensure global compliance.

In this position, you will have the opportunity to

You will shape the regulatory strategy for Vital Signs Monitoring Platforms and have direct impact on global software and platform releases.
This role combines leadership, regulatory expertise, and innovation with a clear contribution to patient safety and business success.

What is the challenge of this role?

Managing complex platform and software submissions with multiple features and devices under strict regulatory requirements, while leading experts and aligning multiple global stakeholders.

How do you contribute to Philips’ success?

By enabling timely, high‑quality regulatory approvals, you ensure global market access for critical monitoring solutions and support Philips’ commitment to patient safety and innovation.

Key Responsibilities (max. 5)

Lead and develop Regulatory SMEs for Monitoring Platforms and Solutions

Oversee complex regulatory submissions, especially U.S. 510(k)

Translate global regulatory requirements into product and software development

Provide regulatory training and guidance to internal stakeholders

Drive cross‑functional alignment across the product lifecycle

You're the right fit if:

• You have 10+ years of Regulatory experience, including U.S. 510(k) submissions for vital signs monitoring platforms

• You are experienced in global medical device regulations and standards

• You have led complex software‑based regulatory submissions

• You bring project/program management experience

• You have strong coaching and leadership skills

• Master’s or Diploma degree

• Field of study: Regulatory Affairs / 510(k) experience

• Fluent in English

• 3–5 years of leadership or program management experience preferred

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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.

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.
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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.