Junior Regulatory Coordinator – Medical Device – Chesham – £22 000DOE
An exciting opportunity has arisen for this highly innovative company within the Medical Device sector. Currently seeking Junior Regulatory Coordinator who will be part of a world-class team to transform the practice of cancer surgery and will play a key role in the company’s product development plans.
* Support the Regulatory Coordinator to ensure that existing product documentation is maintained and kept up-to-date.
* Prepare reports on product performance in the market including adverse events and produce Post Market Surveillance statistics.
* Set, communicate and train regulatory standards in the company in support of the Regulatory Coordinator.
* Support the Product Development manager is producing product test strategies.
* Create and execute test plans and scripts on the systems being built.
* Research into UKAS accredited laboratories / affiliates to conduct validation testing such as regulatory type testing.
* Involvement in design reviews and audits and preparation of the presentations.
* Execute the validation testing of products in development.
Skills experience should include:
* Some experience in development, production test systems, regulatory affairs or governance in a structured environment.
* An understanding of the full product lifecycle, with a focus on product development.
* Keen to learn, have a good eye for detail and good organisational skills.
* Have excellent written and oral communications skills to communicate clearly and effectively with third parties, regulatory authorities and management.
* An understanding of current EU medical device regulations.
* Looking for a company where they may broaden their experience and grow with the company.
* You will be process driven with a can-do approach to find fitting and effective solutions to move projects forward.
Education and Experience required as a Minimum:
Degree or equivalent.
stream is acting as an Employment Agency in relation to this vacancy.