Our Multinational Healthcare Client has a requirement for an experienced Reg Affairs Specialist for a fixed term contract until the end of 2021. This opportunity can be offered on a remote basis. This person will join a well established team with a great company who offer good work/life balance, culture etc
- Development and implementation of registration strategies for new product launches.
- Preparation and submission of 510k for US clearance.
- Preparation and maintenance of CE technical files
- RA representative on Design Change projects
- Preparation and submission of dossiers and registration documentation for new product registrations and renewal of existing licenses.
- Management of Field Action process for products.
- Review and approval of device modification proposals.
- Review and approval of all product labelling.
- Control of distribution of product from regulatory perspective through regulatory stop ship program
- Communication to management on Regulatory affairs issues, which require addressing.
- Support, where required, in Global RA tasks / projects
Education & Experience:
- Will be qualified to a minimum of B.Sc. level in a scientific field or other relevant technical field.
- Have a minimum of 3 years’ experience in a QA or RA role within a manufacturing facility.
- Excellent written and communication skills are essential, which will result in strong working relationships cross functionally within BCII
Ability to work in a very busy environment, ability to manage change effectively in order to better serve our internal customers, external customers and legislative demands