Austin Vita are pleased to offer an exciting opportunity for a hands on Regulatory Engineer to join our client, an innovative medical device business who design, develop and manufacture a range of devices for global markets based in Buckinghamshire. This will be a site based role so suit someone who loves working in a Team and rolling up their sleeves to the broad range of tasks and challenges.
The opportunity comes at a time of site expansion and natural growth within the Quality & Regulatory department, and your responsibilities will include: Working with internal departments and external regulators, suppliers and customers with a broad remit to ensure the ongoing product and systems compliance to the applicable regulations and standards. Assisting in the maintenance and review of technical product files and assist in the continued transfer to the MDR. Working with the design department to ensure ongoing regulatory compliance of current and new products. Collaborating with a team of design engineers to produce a variety of technical documentation (such as essential requirements, risk assessments, test reports, etc). Producing documentation in compliance with the relevant regulatory standards. Working with internal departments, Competent Authorities, other national authorities and our Notified Body on product and company registrations. Working in conjunction with the Sales department to provide the necessa...