The QA/RA Associate shall provide support for the development of innovative medical devices, as part of the Spentys QA/RA team. (S)he will provide support in Quality Assurance and Regulatory Affairs activities such as, but not limited to:
- Quality Management System implementation (writing and monitoring procedures, forms, records, instructions and documents)
- Standards watch and gap analysis to perform when starting new internal projects
- Watch over regulatory aspects for Spentys to start businesses in countries worldwide
- Communicate with the team across departments
- Lead potential projects and dispatch work in the team (ex. GDPR compliancy, ISO27001, ISO13485, etc.)
- Compilation of documentation for notified bodies, FDA, competent authorities
- Implement, improve and maintain the Spentys procedures
- Train the team to follow the procedures
- Answer questions of the team regarding QA/RA aspects
- Communicate, track, and report progress.
- Min. 2 years of relevant experience in medical devices QA/RA functions
- Good understanding of medical devices regulatory environment (MDR)
- Good knowledge of medical devices quality assurance (ISO 13485) and relevant standards
- Fluent in English and French or Dutch
- Be creative, organised and motivated
- Meticulous, understanding and comprehensible
- Knowledge of the medical field is a plus
- Ability to take initiative
What you'll get
- A thriving, entrepreneurial environment in which people matter.
- Being part of a team working on a uniquely innovative and disruptive solution oriented towards the future of healthcare.
- Dynamic and exciting scale-up environment - you won't be a small cog in a big machine.
- You own a crucial aspect of our business, and you will be making a real impact on the business and the quality of life of patients.
- Opportunities to grow within the company.
- Competitive salary and benefits package.
- Start: As soon as possible
- At least for 6 months; convincing candidate will be confirmed for undetermined period