Principal Regulatory Affairs Specialist (Software)

Job Title: Senior Regulatory Affairs Specialist – Software & Medical Devices

Location: Remote (Europe) | Time zones: CET 

Sector: Medical Devices / Digital Health / SaMD

The Role:
We’re seeking a senior Regulatory Affairs professional to lead regulatory strategy and hands-on decision-making for software-heavy medical devices, including clinical software, cloud platforms, and AI/ML-enabled systems. This senior individual contributor role spans strategy, program oversight, and operational RA execution, with strong exposure to EU and FDA frameworks. You will work closely with engineering, QA, and product teams to ensure compliant, risk-based decisions across multi-device and software portfolios.

What You’ll Do:

Regulatory Strategy

• Provide strategic oversight of clinical and software ecosystems

• Lead long-term regulatory planning across device and software portfolios

• Shape regulatory decisions aligned with product and business strategy

Software & Device Classification

• Assess whether software qualifies as a medical device

• Make regulatory judgment calls on software interfaces, clinical tools, and standalone vs. non-medical software

• Coach teams on RA requirements even for non-medical software

Documentation & Submissions

• Build regulatory documentation for submissions and internal compliance

• Decide when documentation is required, with emphasis on interpretation and judgment

Product & Technology Collaboration

• Work with devices deployed in clinics alongside internally developed clinical software

• Collaborate closely with software engineers and QA teams

• Support software platforms including clinical experience (CX) tools, medical, and non-medical systems

• Bring deep understanding of modern software architectures, cloud services, DevOps pipelines, and AI/ML

Must-Have Experience:

• Senior RA experience in medical devices or medical software

• Strong knowledge of EU MDR and/or FDA regulations

• Experience in software-heavy medical device environments

• Expertise in software medical device qualification and classification

• Proven ability to create and assess regulatory documentation

• Comfortable working cross-functionally with engineering, QA, and product teams

Desirable Experience:

• Supporting clinical software, cloud-based systems, or SaaS platforms

• Knowledge of SaMD, standalone software, and non-medical software boundaries

• Experience with AI/ML-enabled medical software

• Background in imaging, radiology, hospital IT systems, or medtech start-ups/SMEs

• Exposure to RA operations, certifications, and management systems

• Multi-device/program portfolio experience

Why This Role:

This is a senior individual contributor role with significant exposure to strategic decision-making, multi-device portfolios, and cutting-edge medical software. You’ll be part of a collaborative, cross-functional team shaping regulatory strategy for innovative digital health solutions.
 

Ready to Apply?
If this role matches your experience and career goals, we’d love to hear from you. Please send your CV and a brief note highlighting your relevant RA experience to a.brenner@panda-int.com

We review applications on a rolling basis, so don’t wait - get in touch and take the next step in shaping the future of software-driven medical devices.