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We are looking for a Senior Quality Assurance and Regulatory Affairs Specialist to join a Cambridge based team to provide company-wide regulatory support to project teams, spanning both medical and non-medical disciplines, as well as supporting the QA Manager and Head of RA with operational activities of the Quality Management System and related management systems.
Ideally you will already have strong experience in the regulatory field, and this role will offer you the chance to utilise this to provide a strategic advantage to client projects while expanding knowledge and experience of European, US and Asian regulations (for both medical and non-medical applications). You will also lead communication regarding key changes in the regulatory fields and interpret what they mean for both the team and the wider business.
* Degree in Engineering or Life Sciences
* Ability to demonstrate a track record of developing and executing global regulatory strategies that align with business needs and deliverables
* Previous experience with medical devices is strongly preferred
* Skill and experience to interpret regulatory and standard requirements to ensure the downstream implications for processes are clear
[ Cambridge, Salary £neg. | vacancy reference : 32665 ]