As a Regulatory Affairs Associate you will be responsible for ensuring all the devices meet the regulatory requirements of the Medical Devices Directive 93/42/EEC as amended by 2007/47/EEC and the Medical Devices Regulation 2027/745 EU. As well as, updating Technical & Master File Documentation to meet new requirements as laid out by MDR and undertaking clinical evaluations in accordance with MEDDEV 2.7/1 rev 4. Some of your key tasks and responsibilities will include:
- Updating technical file information, with respect to product and process changes, addition of new products and discontinuing products as required.
- Undertaking product registrations overseas
- Carrying out clinical research on new products, sourcing clinical articles and web-based information on new products.
- Analysing clinical data and compiling detailed clinical and regulatory reports.
- Writing contracts and dealing with suppliers sourcing documentation as required.
- Working on MDR Remediation activities - completing templates and updating existing information to meet new requirements as specified by the Head of RA.
- Compiling protocols and reports for PMS / PMSR reports and SSCPs.
- Analysing data and preparing data and reports as required by the Head of RA.
- Maintaining standards of quality set by the company as regards attention to detail and accuracy of all work undertaken.
As the ideal candidate you will have a degree in a suitable scientific discipline along with 5 years' experience in the medical device industry, within a regulatory role with exposure to writing/updating of technical files to MDD or MDR. It is essential you have working knowledge of ISO 13485, FDA QSR 820 ISO 14971 and MEDDEV, NBOG and MDCG Guidance's.
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