RA / QA Manager - Broad role for Technical Devices

An innovative medical devices company who develops a software technology used by physicians to improve clinical outcomes is looking for an RA/QA Manager. This is a new position which means there is more room to personalise the role. There is only 1 other person in the RA/QA team so the responsibilities within the role are more diverse and it will not become like routine work.

The current role is already a combination of operational and strategic tasks but because the company is growing you could be the person to start developing the team in the future and take on more management responsibilities like hiring for your own team. You will see a lot more the value you bring than in a larger organisation.

Some examples of your responsibilities:

• Manage the quality management system
• Identify regulatory requirements in collaboration with Regulatory Affairs, perform gap analyses and coordinate the implementation
• Maintain the quality policy, quality objectives, and quality manual including process overview, key performance indicators
• Develop and review the regulatory strategy
• Manage regulatory submissions, registrations and notifications
• Manage vigilance activities

Profile:

• Master Degree or PhD in Life Sciences, Engineering or Computer Science
• Some years experience within Regulatory Affairs and/or Quality Assurance for the medical devices or diagnostics industry
• Good knowledge of ISO 13485 is preferred
• Fluent level of English

If this job appeals to you please apply here or send your CV to me, Annelies De Baere, on the NonStop Recruitment website or 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 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.