UgenTec is an international and fast-growing bio-IT company specialized in the development of diagnostics software for DNA interpretation and analysis. The UgenTec software solution is situated on the challenging crossroad between IT, data science and molecular diagnostics.
We’re on a mission to heavily disrupt our market and are already recognized with multiple awards that confirm the value and promise of that mission. The UgenTec headquarters are located in Hasselt at the Corda Campus where a growing team of highly motivated talents is quickly moving from spin-off, to scale-up, to an international enterprise.
As the head of quality and regulatory affairs, you are
- Responsible for the regulatory strategy of the UgenTec products in a continuously evolving regulatory landscape, including :
- compliance to local and global legislation, guidelines and regulations
- adapting the quality management system upon changes in applicable regulations
- regulatory submissions of applications to obtain authorization for marketing in various jurisdictions
- main contact for our customer on regulatory affairs.
- Accountable for the quality management systems (ISO13485 - ISO27001)
- Accountable for the preparation, execution and/or hosting of internal and external audits (notified body, FDA, competent authorities and customers)
- Leading customer specific quality and regulatory affairs discussions and promoting the awareness of regulatory and customer requirements throughout the organization
- Team lead of the QA/RA team. People management of the QA/RA team members.
For this function we are looking for someone with
- A master scientific or IT degree or equivalent via experience
- Strong affinity with IT systems and/or molecular biology
- Proficient in quality management
- Experience with the implementation of iso standards and medical device regulations (ISO13485, IEC 62304, ISO15189, IVDR, …) or equivalent
- Strong communication skills
- Customer- and solution-oriented
- Fluent in Dutch and English, verbal and written
- Demonstrating initiative and sense of responsibility
- Organized and conscientious
- Passionate and self-motivating
Why join UgenTec?
UgenTec stands for a stimulating atmosphere where you can grow your capabilities in an open and no-nonsense company culture. We offer a fascinating role with continuous learning in an international environment. UgenTec offers a fascinating job, where you can drive the regulatory direction, a competitive salary and fringe benefits.