Austin Vita are excited to be representing a well-established brand in the Medical Device Industry. Our client provides attractive opportunities for progression, and are eager to get products out to market, allowing employees to see the true benefit of their work.
The role is based at the clients' Head Office, based in the North of Yorkshire. Our client is an award-winning specialist in producing Medical Devices used for patients in critical care.
As an R&D Associate, you will be working in a team to ensure the compliance of both new and existing products with Medical Device Regulations. This will include the writing and reviewing of technical documentation, supporting the product validation and verification, and you will also be involved in the development of new innovations.
To provide accurate and current R&D input to support the development and compliance of medical devices launched and marketed by the client
Generation of documentation in the areas of design history, product and production validation and verification, usability and technical transfer.
Working with external partners, such as laboratories, to run studies, ensuring the studies are planned correctly and delivered to agreed timings.
Working as part of a cross functional project team, in partnership with the New Product Development team to deliver new medical device innovations.
Working as part of a cross functional project team delivering changes to the existing portfolio of medical devices marketed by the client
Ensuring documentation is generated for regulatory technical dossiers to agreed timelines and to a good standard.
Participating in regulatory/quality system audits (internal and external) where required.
Provide input in to change control process, impact assessments and actions required as a result of the change.
To be successful, you should have an understanding of the MDR and medical Device ISO standards, including 13485, 14971, 10993 and 62366. Furthermore, you should be experienced in handling and reviewing technical documentation. It would be advantageous if you have a degree or equivalent in an engineering, science or medical discipline.
For immediate consideration please forward your most up to date CV.
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.