My client, a medical device manufacturer based in Dunfermline, have an exciting opportunity to join their Regulatory Affairs team in the post of Regulatory Associate. Working to provide support and guidance to the wider company with regards to regulatory reviews, testing and submissions you will also be responsible for the maintenance of all technical documentation in this regard. The successful candidate will also represent this team in cross functional projects and provide training and support on correct procedures and processes. Reporting to the Compliance Development Director you will be an integral part of the department.
A growing medical device company, operating on a global platform that specialises in the diagnosis, treatment and prevention of retinal diseases and disorders. With over 25 years’ experience within this sector to draw upon they are at the forefront of innovation. Placing high importance on work/life balance the company believe that professional and personal goals are of equal importance and provide an environment where both can be realised. A competitive salary and extensive benefits package are offered complementing a friendly and supportive company environment and valued employee ethos.
A competitive salary is offered backed by an extensive benefits package including generous annual leave, company bonus, contributory pension, flexi-time, private health care and insurance schemes. The company believe their employees are their most valuable asset.
Knowledge of regulations pertaining to medical devices is essential to this role and my client is open to this being gained either within a commercial or academic environment. This role would suit someone that has started their career in regulatory affairs or someone that has recently graduated in a regulatory discipline (ideally with an industrial placement year) and is looking to take their first role in this arena. An understanding of ISO 9001 and ISO 13485 is essential, as is a knowledge of medical product procedures for FDA and MHRA approval. An understanding of medical device approval in other countries and medical device software would be extremely advantageous.
Please get in touch to find out more about this opportunity.
|Job Title:||Regulatory Associate|
|Salary:||Up to £35,000 depending on experience|
|Contact Name:||Julie McEwan|
|Job Published:||September 05, 2018 16:13|
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