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Regulatory Affairs and Quality Assurance Specialist - Extended closing date

Maastricht, Nederland

About the Role

We are looking for:
As a Regulatory Affairs and Quality Assurance Specialist, you will be responsible for implementing Quality by design in the development phases of our products and later the timely regulatory compliance of the products of a small biomedical startup. Since the company is in an early phase of infrastructure and technology development where RA/QA activities will be limited, partial responsibilities of facility management, health and safety implementation, and risk assessment analysis will initially also come under this position. In this role, your tasks will include:
• Understanding the regulatory landscape related to the company’s products (GMP Eudralex Vol 4 , GMP’s for ATMP’s and/or MD ISO 13485) and working closely with the technical team to help them make the processes and products compliant by design
• Overseeing the implementation of the Quality Management System including Quality Assurance processes to ensure product safety and quality as well as to meet the regulatory demands, including cleanroom validation and management and process and product quality control
• Attending regular trainings and maintaining own certifications updated to stay qualified for the above tasks
• Training the company staff on relevant safety and regulatory aspects
• In the initial phase, support with the timely application of permits at relevant regulatory authorities for the desired operations of the company, with the support of external consultants if needed
• In the initial phase, support with the setting up and enforcing of operational safety protocols at work, including biological safety
• In the initial phase, support with the risk assessment analysis of the facilities as well as the processes

About the Company

Are you someone who is passionate about quality and safety of research- and clinical-grade biological products, and someone who enjoys finding paths of product translation through navigation of regulations? Would you like to work in an international, small-scale environment with large societal impact? Then we have an interesting job for you at ReGEN Biomedical.
ReGEN Biomedical is a startup company that aims to revolutionize the manufacturing of large numbers of high quality functional micro-tissues for drug testing and regenerative medicine therapies. Would you like to help us achieve this goal?

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