Description
This business has set big goals for the next 4 years to double their turnover from 10 Million to 20 Million, to hit this goal there is going to be an increase in new products to market and global registration of existing products. Because of this there is now the need for a QA/RA Manager to manage the Regulatory and Quality function behind this.Main responsibilities include;
- Provide strategic leadership, to successfully manage and coming product launch.
- Compilation of product dossiers for Regulatory Submissions.
- Ensure products are successfully CE marked by relevant authorities.
- Implement a QA system upgrade to an electronic management system.
- Management of current QA function.
- Recruitment and development of Regulatory Affairs team.
Essential Requirements;
- Substantial proven Regulatory Management experience in a Medical Device company.
- Experience of strategic & hands on regulatory affairs.
- Previous successful 510k submissions.
- Previous interaction with the European and USA regulatory bodies.
- Experience with the regulatory and quality procedures connected with class III &Class II Medical Devices.
- Experience of the management of a Medical Device Quality management system to ISO 13485.
My client is currently short listing for this role so if you believe you have the right experience then please send me your CV and I will be in touch shortly.