Regulatory Compliance Director - Global strategic role

A growing diagnostic company is looking for a Regulatory Compliance Director to lead the regulatory department and global registrations. The company is headquartered in Belgium so you will be close to all the decision-making and will be able to have a positive impact on building and improving the regulatory processes globally.

They also stepped on the train to support in the corona crisis by developing and distributing covid-19 test kits and are predicting a company growth because of this, meaning you can give your input to help in the crisis and also be a part of the company's growth.

Responsibilities:

• Lead and review of the technical documentation
• Prepare the regulatory submissions to all regulatory authorities
• Establish and maintain post-market surveillance activities
• Implement IVDR requirements
• Vigilance reporting and overseeing vigilance activities including complaint handling
• Responsible contact person for the authorities, external partners and investigators
• Collaborate with the R&D teams to implement compliance processes according to regulations and standards

Requirements:

• Master Degree or PhD in Life Sciences or Engineering, or equivalent by experience
• Multiple years of experience in Regulatory Affairs for the medical device or diagnostics industry
• Strong experience with medical device vigilance reporting and complaint management
• Experience within a team leader or management role
• RAC certification is a plus
• Strong knowledge of QMS and GMP under ISO 13485
• Fluent level of English

Benefits:

• Market rate basic salary and attractive benefit package
• Join growing company with future career opportunities

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