Regulatory Affairs Intern - IVD/MD

About the role

Roche is looking for a creative, innovative and open-minded intern to join its Global Regulatory Affairs team in Sant Cugat del Vallès. The intern supports regulatory and product care activities for IVD/MD products and gains insight into the industry's regulations and standards. The internship lasts 12 months and includes exposure to AI tools used in regulatory work.

Key responsibilities

• After onboarding, assist in worldwide registrations and activities for IVD/MD products at different stages of their lifecycle
• Support the preparation and maintenance of global documentation for IVD/MD products
• Collaborate with local affiliate regulatory teams on registrational activities
• Coordinate with global project teams to give regulatory input to development, submission planning and documentation
• Support regulatory affairs colleagues with their non-registrational activities
• Help design, develop and test AI-powered tools and dashboards for regulatory tracking, document analysis and automated reporting
• Take part in training and fine-tuning AI tools for regulatory use cases, keeping up with emerging AI technologies and changing regulatory guidelines

Required profile

• Recent graduate (within the last 3 years) in Biology, Life Sciences, Engineering or Data Science
• Fluent English, written and spoken
• Facilitation and communication skills, able to work in a multicultural, international environment
• Fast learner, proactive, team-oriented, curious and detail-oriented

Required skills

• Familiarity with AI tools
• Prompt engineering

What we offer

• Hands-on experience with real-world AI applications in a highly regulated environment
• Exposure to end-to-end IVD/MD development and other functions, with a mentoring team
• Flexible working arrangements and a collaborative team culture