job description
Join Roche, a global leader in healthcare innovation, for a transformative Regulatory Affairs Internship focused on medical devices. This role offers a unique opportunity to gain hands-on experience in quality compliance, regulatory submissions, and industry best practices within a dynamic, international environment.
Based in Bali (with remote/hybrid flexibility), you'll collaborate with cross-functional teams to ensure adherence to global regulatory standards. Ideal for aspiring professionals in healthcare, life sciences, or engineering, this internship provides mentorship, real-world projects, and a pathway to impact patient safety worldwide.
Why Roche? Work alongside industry experts, access cutting-edge training, and contribute to life-changing medical technologies. Bali's vibrant ecosystem offers an inspiring backdrop for professional growth.
Responsibility
- Assist in preparing and reviewing regulatory submissions for medical devices in compliance with global standards (e.g., FDA, EU MDR).
- Support documentation management for quality assurance, including technical files and risk assessments.
- Collaborate with R&D and manufacturing teams to ensure regulatory requirements are integrated into product development.
- Monitor and analyze regulatory updates, communicating changes to internal stakeholders.
- Participate in audits and inspections, preparing necessary documentation and follow-up actions.
- Conduct research on regional regulatory requirements for market access strategies.
- Contribute to post-market surveillance activities, including complaint handling and reporting.
Qualifications
- Currently pursuing or recently completed a degree in Life Sciences, Biomedical Engineering, Pharmacy, or related fields.
- Basic understanding of regulatory frameworks (e.g., ISO 13485, FDA 21 CFR) is a plus.
- Strong analytical skills with attention to detail in documentation and compliance.
- Proficiency in English (written and verbal); additional languages are advantageous.
- Ability to work independently and collaboratively in a fast-paced environment.
- Familiarity with Microsoft Office Suite; experience with regulatory databases is beneficial.
- Passion for healthcare innovation and commitment to ethical standards.