Quality Management & Regulatory Affairs Intern
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Job Location:
Zürich - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
Internship: Quality Management & Regulatory Affairs
The Challenge
We are currently evolving the way we manage quality and safety for our EU MDR Class IIa medical device. As we scale we are transitioning our entire Quality Management System (QMS) and Technical Documentation into a new state-of-the-art software environment.
We are looking for a motivated Masters student (or recent graduate) to support the refactoring of our risk management and help us build a more agile software-driven compliance framework.
Your Responsibilities
- Risk Management Refactoring: Analyze and restructure existing risk management files (ISO 14971) to ensure they are robust scalable and fully compliant with ISO 13485 ISO 14971 EU MDR and FDA requirements.
- Digital Transformation: Support the transfer of Technical Documentation and QMS structures from Gitlab into our new software tool Matrix Requirements.
- Process Engineering: You will design develop and implement improved QMS processes that make life easier for our engineering and customer facing teams.
- Knowledge Transfer: You will be the power user of the new system. This includes creating documentation and conducting training sessions to ensure the team is up to speed.
Your Profile
- Education: You are currently enrolled in or have recently completed a Master of Science (.) in Biomedical Engineering Regulatory Affairs Life Sciences Health Sciences or a related technical field.
- Regulatory Interest: You are interested in understanding the regulatory landscape of a medical device company under ISO 13485 and ISO 14971.
- Analytical Mindset: You enjoy untangling complex systems and turning them into clean logical structures.
- Communicator: You can translate complex regulatory requirements into clear instructions for others.
- Tech-Savvy: You are comfortable working with eQuality Management System or Application Lifecycle Management software tools and have an interest in digital compliance.
What We Offer
- Real Impact: You will be responsible for core components of a Class IIa medical devices compliance strategy.
- Flexibility: We offer flexible work hours to accommodate your studies or personal schedule.
- Dynamic Culture: Join a young driven team that moves fast and values new ideas.
- Career Growth: Deep-dive into QMS process development and risk management core skills in the MedTech industry.
Timeframe: 6 months. Were looking for someone to grow with us through this transition.
Required Experience:
Intern
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Join Us in Shaping the Future of Medical Imaging At Positrigo, we are driven by our vision of imaging everyone—having developed a very compact and cost-effective brain PET system to revolutionize nuclear medical imaging. Our mission is to make advanced diagnostics widely accessible, e ... View more
