Cure Talent are excited to be working with a market leading MedTech manufacturer, specialising in innovative surgical products, based in the heart of the home counties. Due to their exceptional continued growth, we have a superb opportunity for a Regulatory Affairs Engineer to join the team.
As the new Regulatory Affairs Engineer, you will be working closely with the Head of QARA and as a part of an established team of Regulatory and Quality professionals. You will be involved in Product Registrations, Post Market Surveillance, Customer Complaints and CAPA reporting.
To be successful as the new Regulatory Affairs Engineer we are looking for an experienced MedTech Regulatory Affairs professional with proven experience of the maintenance and development of Technical Files under MDR. Work 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.
Work with the design department to ensure ongoing regulatory compliance of current and new products.
Collaborate with a team of design engineers to produce a variety of technical documentation (such as risk assessments, test reports, etc).
Assist in the actioning, monitoring and reviewing of NCRs, customer complaints, CAPA reports and return in warranty failures, assisting with the identification and implementation of corrective / preventative actions to continuously improve on these.
Proven Regulatory Affairs Experience within the Medical Device sector.
Broad background in quality and regulatory compliance of systems and products essential.
Broad background in electro/mechanical products essential, along with an understanding of the impact of regulatory requirements.
Experience of medical standards and European/ FDA regulations such as ISO 13485, EC 93/42 and MDR highly desirable.
Experience of medical device manufacturing and medical standards desirable.