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. ScreenPoints 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 wont 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.
  

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 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.

Preferred qualifications

• 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.
  

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

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

Required Experience:

Manager