Regulatory Affairs Officer

In the fight against breast cancer, every medical image is an opportunity: to unlock insight, to uncover risk, to embody health, to empower life. ScreenPoint’s Transpara Breast AI delivers unmatched precision for breast radiologists and helps define personalized care pathways for every woman we serve. Make your mark as part of The Breast AI Company.

As our Regulatory Affairs Officer, you won't just be checking boxes. You will be the strategic architect of our global market presence, ensuring our Breast AI innovations reach clinicians and patients faster by navigating the complex intersection of medical devices, AI and global compliance.

In this role, you will act as the subject matter expert for global submissions, drive efficient market access, and streamline regulatory processes to keep us agile. You will collaborate closely with Innovation, Product Management, Engineering, and Commercial teams to align regulatory priorities with business goals, ensuring we remain compliant while optimizing our global submission efforts.

Your responsibilities

• Global Regulatory Strategy & Market Prioritization: Define and implement efficient global regulatory strategies for medical software. Lead discussions on market and country prioritization, advising on whether and when to pursue market access.
  


• Regulatory Submissions & Lifecycle Management: Lead global submissions and lifecycle activities for new and existing products across the EU, US, and Rest of World. Ensure compliant and high-quality submissions.
  


• Regulatory Efficiency & Process Improvement: Streamline regulatory processes, maximize reuse of approvals and documentation, and minimize unnecessary submissions.
  


• Regulatory Intelligence & Change Management: Monitor evolving global regulations, perform regulatory change assessments, and provide clear guidance and decisions for product updates and new developments.
  


• Stakeholder & External Communication: Act as a regulatory point of contact for internal teams and external parties, including license holders, authorized representatives, and regulatory partners. Align priorities, timelines, and expectations through clear communication.

Job requirements
You are a proactive and independent regulatory professional with strong knowledge of medical device software regulations and a focus on efficiency and decision-making. You work effectively across teams and with external partners. Furthermore, you have:

• At least 5 years of experience in Regulatory Affairs with medical device software (SaMD).


• Proven track record of global regulatory submissions (e.g. EU MDR, US 510(k), PMA, De Novo, and RoW registrations).
  


• Strong understanding of medical device software regulations, including IEC 62304, ISO 14971, and evolving AI / cybersecurity frameworks.
  


• Excellent communication skills in English.
  


• Ability to manage multiple priorities, complex timelines, and stakeholder expectations.

Preferred qualifications

• Experience with cloud-based or SaaS solutions.
  


• Direct interaction with Notified Bodies and/or FDA.
  


• Knowledge of breast radiology, oncology, and/or breast MRI workflows, including diagnostic flow and clinical practice.

About us

ScreenPoint Medical is a leading company that develops and markets breast image analysis and cutting edge machine learning applications and services. Our product Transpara improves breast cancer survival rates by detecting cancers earlier so that treatment can be more effective and less invasive.

Do you want to help us build an innovative solution to improve health worldwide? And do you want to be part of an ambitious and fast-growing team who help you develop your career further? Please apply using the application button.

Providing a Certificate of Conduct (VOG) or background check is part of our application procedure. Questions about the contents of the vacancy or the recruitment process at ScreenPoint Medical? Please send an email to [email protected]. 

Providing a Certificate of Conduct (VOG) or background check is part of our application procedure. Questions about the contents of the vacancy or the recruitment process at ScreenPoint Medical? Please send an email to [email protected].