Are you our Quality Manager to enable rapid growth?
We're looking for an experienced Quality Assurance / Regulatory Assurance (QARA) specialist with proven skills from the medical device or pharma software systems industry. You understand the relationship between relevant regulatory frameworks and a fast-moving agile development process. You're a highly structured person, self-starter with attention to detail and you take pride in using your quality work as an enabler and accelerator for the product teams ensuring any roadblocks are cleared from their path. You are an integrated part of a passionate and fast-moving team developing and providing a state-of-the-art global service.
You don't mind getting your hands dirty and partake in technical and practical quality activities to experience first hand how a well-oiled product development machine should be run.
In this role, you will acquire unique competences in enabling entrepreneurship in the medical and pharma industries.
Responsibilities
- Take ownership of our QMS and continuously optimize it and build in new regulatory requirements
- Stay up to date with clinical and pharma regulatory frameworks, standards, and guidelines, such as MDR, ISO 13485, GAMP 5, 21 CFR Part 11, Annex 11 and ISO27001
- Actively incorporate other relevant regulatory frameworks into our processes, such as data privacy legislation
- Run internal reviews, act as an audit frontline and perform vendor assessments
- Train the organization and ensure compliance
- Ensure Quality Assurance is an enabler and accelerator to the product development team, working hand in hand with an agile process
Skills And Qualifications
' Experience running QARA processes
- Formal training and practical experience implementing in a few of MDR, ISO 13485, GAMP 5, 21 CFR Part 11, Annex 11, and other relevant frameworks in a software environment
- Understanding of agile software development in a regulated industry
- Drive all your work in English
Extra points
- Relevant certifications
- Contributor to any Special Interest Groups developing these frameworks
