Regulatory Affairs Specialist, IVD/ Medical Devices
Location: Manchester, 3 days office 2 working from home/ remote.
Hours: Monday to Friday 9:00am - 5:00pm
Reports to: Senior RA Specialist/RA Manager
Additional: Parking onsite, 3/5% pension contribution, Life Assurance, Private Medical
Additional: Share incentive scheme, online learning toolkit, 25 days AL + BH and Birthdays etc
Our Client, an IVD company are looking to add to their existing RA team and recruit for an RA Specialist who will progress within the ranks there.
This role will help support the RA team according to the organisation's regulatory affairs strategy. The role requires understanding of the current IVD regulatory framework and processes and the IVDD to IVDR transition.
- Maintenance of technical documentation in accordance with the requirements of IVD and IVDR standards for CE-marking activities. This will include putting them together and ensuring that they are kept up to date.
- Administrate regulatory dossiers to support product license applications.
- Maintain specialist knowledge and tracking of the regulatory requirements for the UK, US/Canada, EMEA and the Asia-pacific regions.
- Help with the development of the companies regulatory planning in accordance with global requirements.
- Assist product risk management activities and the life cycle of marketed products.
- Support post market surveillance and then prepare reports for the product range.
- Support the regulatory requirements of the product development process, contributing to product validation plans, reports, claim support papers and other post market activities.
- Conduct duties in compliance with GMP, ISO13485 and ISO9001.
- Degree in a life science or equivalent (e.g.- biomedical, genetics, molecular biology)
- Previous experience working in a IVD regulatory role
- Awareness of the IVDD and IVDR transition.
- At least 6 months experience in the regulatory field- it is essential that this candidate has experience with product registration. Additionally experience outside of the UK including US, Asia Pacific, Europe, or the Middle East would be ideal.
- Must have experience with technical documentation (putting them together and ensuring that they are kept up to date).
- Knowledge of ISO 13485
- Excellent organisational skills and an ability to work to tight timelines.
- Demonstrate strong team skills.
- Proficient in the use of IT, including Microsoft Office suite and Electronic Document Management systems.
- Excellent communication skills when liaising within the company and with external customers.