Quality Assurance and Regulatory - Associate Manager
moveUP is a fast growing scale up in Digital Health. As we are serious about digital health applications and the benefits it can bring to patients, care providers and society, we also demand the highest quality standards and regulatory compliance from ourselves and our products. Part of our growth means investing in this domain, and that is why we are looking for candidates to join us in this exciting journey.
As a Quality Assurance and Regulatory Associate Manager you'll work closely together with the Quality & Regulatory Manager. Your primary tasks consist of the following: keeping technical file(s) up to date, planning and monitoring clinical evaluation & validation, track and maintain requirements in line with medical device regulation and preparing & conducting company and product audits.
You'll also apply GDPR and IT security processes and principles.
For this tactical and strategically important position you'll help us to:
- Solve and prevent problems (capa management)
- Inspect and select suppliers (software validation & supplier management)
- Keep the business running (business continuity)
- Think strategically (compliance strategy)
- Assure quality (product verification)
- You have a minimum of 1 to 2 years experience in regulatory affairs & quality assurance
- You have experience in clinical evaluation and studies
- You have a bachelor (minimum) or master degree and experience in the medical sector (medical devices) and/or legal/regulatory sector.
- Knowledge of Quality Management (ISO 13485) and Medical Device Regulation (MDD/MDR) are required. Knowledge of ISO 14155, ISO 27001 of GDPR are considered a plus.
- You have strong written and verbal communication skills in English. Dutch preferred. French and German considered a plus.
- Preferred residence in Belgium but not a must.
- You are eager to apply regulatory guidelines and regulation in practice.
- You are able to work independently and keep track of your planning & deadlines in line with team and company milestones.
- You work precise and your administration/reporting is complete and tidy.
- You thrive in a quickly changing environment that challenges your multi-tasking skills
- You have affinity with digital (health) applications
We offer you:
- A full time contract
- An exciting and important spot in an ambitious and fast-growing organization
- Attractive remuneration package
- Attractive and flexible working location(s)
- Great colleagues
You probably want to be considered seriously, so please also treat this application in the same way. Share your motivation why you want to do this, and why you believe you will succeed.
If you want to become part of the journey of a promising & growing digital health company, please apply via https://moveup.recruitee.com/
We are looking forward to hear from you!