My client is a world leader in the manufacture of medical devices. They produce one of the broadest ranges of orthopedic products on the market and also have a significant presence in other medical specialties. They are seeking an experienced regulatory professional to join their team in Berkshire to provide regulatory support for all post market activities across the UK & Ire region.
As Regulatory Affairs Specialist, you will be responsible for ensuring that the business meets all PMS requirements as stated in the Medical Device Directive. Aspects that will often have to be dealt with will be customer complaints, product holds and product field actions. RAQA metrics will need to be met while ensuring that all products are maintaining compliance through internal audits, BSI audits & supplier approval. The role will also require you to deputize in the RAQA manager’s absence and represent the regulatory affairs department at weekly cross-functional team meetings. You will act as the key contact for communications with the UK and Irish competent authorities and there will also be the opportunity to provide training to new RAQA staff on regulatory standards and processes. There is also the exciting opportunity of assisting with the launch strategy of new products and supporting with their regulatory compliance. Standard Operating Procedures will also need to be reviewed and developed by you to ensure they all adhere to regulatory requirements.
Key Qualifications/Experience needed include:
- Degree educated or equivalent (Scientific, engineering or law background preferable but not essential)
- Minimum of 3 years’ experience in Medical Device Regulatory Affairs
- Knowledge of the Medical Devices Directive and associated local laws
- Experience of interaction with competent authorities or notified bodies