Regulatory Expert
1 day ago
Job Title: Senior Specialist- Regulatory Affairs
At ARC Regulatory Ltd, we are seeking a highly skilled and experienced Senior Specialist- Regulatory Affairs to join our team. This role will be responsible for providing regulatory expertise to support the development and delivery of global compliance solutions to client companies.
We estimate the salary for this position to be around £60,000 - £80,000 per annum, depending on experience and location.
Job Description:- Contribute to the development and delivery of global compliance solutions to client companies, ensuring that client objectives are met and exceeded at all times.
- Support the work of the company and project teams in the provision of specialised regulatory expertise to client companies, ensuring that internal procedures and client expectations and interests are met.
- Bring considerable experience in IVD/CDx development, validation and approval to client organisations, providing expert strategies and guidance to their development programmes.
- Engineering or Scientific honours degree or equivalent (10+ years) relevant industry experience
- 5+ years experience of working in a medical device/IVD manufacturing or regulatory environment
- Experience with IVD/CDx design and development, from feasibility to approval
- Knowledge of regulations in key global markets as they pertain to IVD and/or CDx devices (e.g. EU/US)
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