QA/RA Manager FlowView Diagnostics
Company overview
FlowView Diagnostics is a startup company founded in August 2020 as a spin-out from the University Medical Center Utrecht and the Radboud University Nijmegen. We are on a mission to fundamentally improve the standardization and interpretation of complex clinical diagnostics data sets. We need, therefore, to raise the quality of interpretation, of flow cytometry datasets by automating the analysis and advanced interpretation with new algorithms. Such a fast diagnostic work-up will allow clinicians to refine their treatment decision. The company developed a unique algorithm (‘eclipse’) to automatically analyze multi-variate datasets generated by flow cytometry technology.
Job description
FlowView Diagnostics is working towards obtaining ISO 13485 certification in the upcoming months. About 80% of the QMS is ready. Also the first steps for FDA 510K submission will be taken in the next months. The manager of Quality Assurance and Regulatory Affairs (QA/RA) is responsible for ensuring that product development and production meets the current standards and regulations. The function provides oversight of all compliance aspects on site as well as country-specific regulatory clearances and registrations for the company. The QA/RA Manager ensures the safety, efficacy and quality of medical devices and services offered. This is carried out via the sound application of risk management principles and through full compliance with all applicable quality, regulatory and legislative requirements. FlowView is assisted by a sr. consultant who will remain available to assist the new QA/RA Manager.
Key responsibilities
- Establish and maintain the document control and records management process in alignment with applicable regulations
- Ensure Quality Records are maintained according to the procedure and the Quality Records Matrix
- Assist in internal and external audits
- Maintain document / record list(s)
- Maintain revision history of all published document / records
- Ensure content of documents and records addresses needs of functional roles and requirements
- Draft and support quality agreements with relevant external suppliers
- Serve as Project Manager for product and process development
- Be responsible for our regulatory strategy
- Develop regulatory plans for strategic expansion into EU and USA , and other geographies
Requirements for this position
- Minimum of bachelor’s degree in technical or legal discipline
- Experience of at least 1 year or in training
- Strong knowledge of European Directives, Regulations and FDA is a plus
- Critical by nature and like to explore, understand, and get to the bottom of things
- Good verbal and written communication skills with the power to persuade
- Familiarity with MS Office/ MS Project
- Ability to work with data, numbers and literature searches while working accurately
- Affinity with technology, processes and regulations
- Fluent in English and preferably a good knowledge of a second language
- Calm, careful, reliable, well organised, and task-oriented
- Professional Certification (certifications to be maintained as copies)
- Available for at least 32 hours a week and preferable 50% of the time at the office
Benefits and perks
- A small-scale organization where we work based on complementary skills and team reinforcement. And where you as a person really matter!
- Work that has a positive impact on people’s health and life
- An ambitious and independent team where there is plenty of space for your ideas, also those that are out-of-the-box!
- A place where you get a lot of responsibility & freedom to develop your talent.
- An open culture that values entrepreneurship, guts, fun, enthusiasm, and trust.
- Working from home or in the office, both are possible.
- The company offers a permanent position and a competitive remuneration package.
Are you enthusiastic and recognize yourself in the above profile? Then please fill out the form below or e-mail us your application letter: info@flowview.eu If you have questions about the position, please contact Ton van den Hoven CEO (+31-6-11787855). By applying for the job you agree to our privacy statement as mentioned on our website.
Acquisition in response to this advertisement is not appreciated.
