As such, they will support the generation, submission, and follow up of submissions to regulatory Bodies, ensuring both internal processes and key suppliers maintain compliance with current regulatory and quality system requirements.
Duties will include equipment and process validation, the provision of quality input to development teams and during transfer into production, assisting in the investigation of technical problems / non-compliances, providing assistance in auditing of internal and supplier quality systems, and process improvement and CAPA actions.
This role will also extend to working with the pharmaceutical division to maintain awareness of regulatory requirements particularly pharmacovigilance and support the pharmaceutical process and procedures where applicable, also working with the lab group to support processes and procedures for GLP.
They will similarly support the QARA Manager in quality and regulatory decisions and help lead actions to improve understanding of Quality Assurance with in the Business.
Overall, there is a strong emphasis on supporting the product development teams by providing regulatory and quality input to the development and transfer to production for new devices and their manufacturing technologies.
This is truly a wonderful opportunity to join a well respected and innovative company, with excellent growth potential and opportunities for further career development. Interviews will be set up ASAP.
For more information on this vacancy, or any other medical device opportunities, please contact the Senior Consultant Andrew Boroky on 0044 (0) 207 940 2116, or email him at firstname.lastname@example.org .