Real Staffing have been exclusively selected to appoint a Regulatory Affairs Consultant for a Surgical Solutions medical devices manufacturer based in the North West.
You will be responsible for managing the functions of the Quality Assurance & Regulatory Affairs department.
* Ensuring the QMS is complaint to the requirements of ISO13485 and the MDD 93/42/EC.
* Managing all aspects of regulatory/quality audits conducted by regulatory authoritites, notified body, key customers etc..
* Member of Board for the business and a senior management representative for the Heathcare Solutions business.
* Responsible for ensuring any Adverse Incidents and Vigilance reports are addressed as per MHRA requirements.
* Responsible for the Supplier Approval Process ensuring the products supply to our customers are safe and effective.
Successful completion of MIA licence and GMP certificate to support Medicinal Products granted by the MHRA.
* All complaints and non-conformancies are addressed effectively in a timely manner.
Responsible for all Sterilisation & Microbiology aspects of the division, i.e. Sterilisation Validation, dose audits, environmental & bioburden monitoring.
You MUST have experience with the above and extensive regulatory affairs experience within medical device companies.
Regulatory Affairs Consultant Medical Device £55ph North West
Please contact Steven Ruddy from Real Pharma - Medical Devices on 0207 758 7322
To find out more about Real please visit www.realstaffing.com