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 expansion across APAC, LATAM, Middle East and Africa. By navigating the complex intersection of medical devices, AI and Global Compliance, you will ensure our innovations reach clinicians and patients faster.
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 Submissions: Lead global submissions and registrations for new and existing products, with a primary focus on international markets (APAC, LATAM, Middle East and Africa)
- Strategic Market Access: Advise the business on "where and when" to launch. You will define efficient regulatory strategies, prioritizing markets based on commercial impact and regulatory complexity.
- Process Optimization: Move away from one-off efforts. You will streamline regulatory processes, maximizing the reuse of technical documentation and approvals to minimize workload and increase speed-to-market.
- Regulatory Intelligence: Monitor the evolving global landscape, assess the impact of regulatory changes, and provide clear guidance to engineering teams regarding product updates.
- Stakeholder Management: Act as the primary regulatory point of contact for external partners (distributors, authorized representatives) and internal teams, ensuring priorities and timelines are perfectly aligned.
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 3 years of experience in Regulatory Affairs for medical devices.
- Experience with international submissions and registrations (e.g. APAC, LATAM, Middle East and Africa).
- Excellent communication skills in English; ability to manage multiple timelines and external partners effectively.
- Experience with software as a medical device (SaMD)
- Strong understanding of medical device software regulations, including IEC 62304, ISO 14971, and evolving AI / cybersecurity frameworks.
- Experience with US and EU submission (510(k), de Novo, PMA, EU MDR)
- 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.
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 jobs@screenpointmed.com.
#J-18808-Ljbffr€50000 - €70000 monthly