Regulatory Affairs Specialist
Biotechnology Life Sciences
Salary £22,000 - £24,000
We’re working with a globally recognised medical diagnostics organisation as they look for a Regulatory Affairs Specialist. This is a long-term contract (14 months) supporting the Regulatory and Quality team. Whilst predominantly work from home, there will be some travel to our clients site in Newcastle required.
As a Regulatory Affairs Specialist, you will be instrumental in ensuring our clients products meet safety and legislative requirements globally. The focus of this role will be working alongside a specialised team, responsible for the update and upkeep of company product portfolios. You will be helping with the registration of new and existing medical products and liaising with competent health authorities.
- Assist with product registrations in the following territories: EU, Middle East and Africa
- Responsible for registration, notification and assist in file preparation of the entire product portfolio according to local regulatory requirements, where appropriate
- Review and provide input into Tech Files.
- Manage, monitor and promote continuous improvement activities to ensure processes are evaluated constantly for effectiveness.
- Assist with Global Regulatory Intelligence and input into regulatory newsletter.
- Liaison with SU, legal and Regulatory Bodies as required.
Ideally you will have:
- RAQA background or some knowledge of IVD/Device regulations.
- Experience in the preparation and requirements of technical documentation
- Excellent interpersonal skills
- Exceptional analytical, organizational, oral and written communication skills
- Strong presentation and professional writing skills
- Degree qualification in Life Sciences or equivalent experience
This is a great opportunity to join a supportive and friendly team with opportunities for personal development.
Interested… Apply with a CV or contact Owain at CY for an informal chat and more information. – 07851 246839