Description
My client is a multi national Medical Device Manufacturer and that is now looking for a QA/RA Manager - £55,000 to £65,000.Key Accountability:
- Continuous process assurance and improvement.
- Responsibility for maintenance, further development and documentation of the QM systems in the sales organizations in the region.
- Business process analysis and coordination of all QA/RA related activities in above mentioned locations.
- Planning, coordination and performance of internal and external audits if needed also in additional European countries.
- Supervision and handling of incoming complaints as well as coordination and performance of Field Actions instructed through headquarters.
- Report and correction in case of incompliance with existing binding regulations.
- Communication with authorities in coordination with headquarters.
- Monitoring and report of new/changing regulations.
- Participation in working committees and project groups of industrial associations.
Qualification and Experiences:
- University degree (BSc, MSc or equivalent) in a technical discipline, preferably science and a solid background in European Regulatory Affairs, Regulatory compliance and Quality Management Systems with a minimum of 5 years experience in medical device regulatory / quality.
- Detailed knowledge of ISO 13485 standard and the medical Device Directive 93/42/EEC.
- Experience in auditing to ISO 9000 (lead auditor qualification an advantage), ISO 13485, MDD.
- Background in medical technology or healthcare industry.
- Detailed knowledge of quality system and regulatory regulations in Europe.
- Ability to prepare high quality, clear communication materials tailored to the appropriate audience.
My client is currently interviewing so if you think that you have the correct experience then please send me your CV and I will be in touch shortly.