Analyst - Regulatory Management Medical Device

Work Your Magic with us!

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us.

Your Role

As a Regulatory Management Medical Device Analyst within GES VASI, you will be responsible for the regulatory submission of medical devices and IVD’s as per the respective guidelines. The key responsibilities would be

• Familiar with key regulations of key regulatory bodies (FDA, EU, HC, TGA, EU MDR/ IVDR)) and capable of supporting submissions and audits under guidance.
• Familiar with regulatory compliance documents and able to create, track, and update them under supervision.
• Foundational understanding of Technical Documentation (TD) and General Safety and Performance Requirements (GSPR):
• Understands the purpose and structure of TD as per MDR/IVDR
• Recognizes key sections (e.g. device description, labelling, UDI, risk management)
• Familiar with the layout of GSPR and basic compliance expectations
• Can support formatting the document
• Mango/Veeva Vault: Can navigate and use basic features in both: Upload, retrieve, and manage documents, Use version control (check-in/check-out, revisions), Participate in document workflows (review, approval),Tag and classify documents correctly, Track task status in regulatory projects, Understanding of records for different regulatory activities
  
  

Who You Are

• Master’s degree in Life Sciences, Biomedical Engineering, Biotechnology, or a related discipline.
• 0–2 years of experience in Regulatory Affairs, Quality Assurance, or related compliance documentation roles.
• Solid understanding of international regulatory frameworks (FDA, MDR/IVDR, TGA, EMA, etc.).
• Hands-on experience with electronic document management systems (Mango, Veeva Vault).
• Strong attention to detail and commitment to document accuracy.
• Effective communication and collaboration with cross-functional teams.
• Ability to manage multiple tasks and deadlines in a regulated environment.
  
  

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

---