QA/RA Manager - Successful Medical Software

Medical Software which helps with collecting and analysing data is the future! This successful medical software company is looking for an RA/QA Manager to strengthen their internal team. You will be able to really focus on regulatory and quality for software which will give you skills that will increase your employability in the future.

You will be the first person to focus on regulatory and quality internally, currently they are working with a consultant, which means there is still a lot to build and set up. You will report directly to the CEO so this will be an exciting challenge.

Responsibilities:

• Develop and improve the current Quality Management System (QMS)
• Get the ISO 13485 certification
• Perform customers and suppliers audits
• Support customers in implementing the software into their QMS
• Get the medical software approved under MDD/MDR
• Get FDA approval

Requirements:

• Master Degree in Life Sciences, Engineering or Computer Sciences
• Several years of experience in Quality Assurance for the medical device or diagnostics industry
• Good experience with medical software (ISO 62304)
• Experience or knowledge of regulatory framework and processes (MDD/MDR, FDA)
• Fluent level of English

Benefits:

• A market rate basic salary
• An attractive benefit package
• Very flexible working hours and home based work
• Global responsibility in an exciting innovative environment

If this job appeals to you please apply here or on the NonStop Consulting website or send it to me, Annelies De Baere, on my Linkedin. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network.

NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg, US and the Czech Republic and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.