Currently partnering with a Global Medical Device organisation who is a leading in-vitro diagnostic solution provider who are looking for RA Manager. This is an excellent opportunity for you to come in establish and lead their RA strategy in the US to help minimise time to market of their products.
The RA Manager will be there to ensure US regulatory requirements are clearly identified and implemented throughout the product development process to ensure product performance characteristics are compliant with FDA and CLSI requirements for IVD devices. The role is a home based role, with occasionally travel to local office usually this will be once a month.
If you are experienced RA manager with a very strong working knowledge of US registrations process in particular 510(k)'s for in-vitro diagnostics devices as well as having clinical experience, this could be the ideal position for you.
Key roles and responsibilities for the RA Manager are:
- Provide clear, constructive regulatory advice and guidance to global project and product development teams.
- Facilitate alignment with Quality, Marketing and Assay Development groups to support communication and information sharing; with the goal of delivering high quality submission packages.
- Ensure Assay Development activities are aligned with regulatory requirements and timelines that are commensurate with regulatory submission objectives.
- Define US regulatory strategy in conjunction with the Group Director QA/RA; and drive implementation of the strategy.
- Negotiating with US regulatory authorities for marketing authorisation
- Manage and maintain Device registrations in the US
- Review all labelling, marketing and training materials for US regulatory compliance
Key experience required:
- Degree, or higher, in related scientific subject (Chemistry, Biochemistry, Biomedical Science)
- Qualification in RA discipline desirable
- Very strong working knowledge of US registration process, particularly 510(k)'s for in-vitro diagnostic devices.
- Knowledge of US chemical, animal and biological import/export regulations and requirements, e.g. DEFRA,
- A strong background working with IVD Devices
- Minimum of 5 years' experience in Regulatory Affairs functions related to IVD device registration and on market support in the US. Ideally, 2 of the 5 years should have been spent in a managerial position
If you are interested in this position please apply below or contact Gavin Johal at Real Staffing.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales