Quality Assurance and Regulatory Affairs Leader
Permanent with flexible hours
We are searching for an experienced Medical Device professional with established experience in both the disciplines of Quality Assurance and Regulatory Affairs to join an international Medical Device company in an exciting newly created role that has been created through significant growth of the business.
These are exciting times for this Medical Device company; with further growth after a hugely successful 2016, a push on new product introduction and increased registrations into new and existing markets. Accordingly, they need to strengthen their expertise in quality assurance and regulatory affairs and bring on someone to lead a small but experienced team.
For the incoming Quality Assurance and Regulatory professional this is the chance to join a worldwide leader in manufacturing with a long history and solid reputation in their product areas. The company has numerous sites across the UK, Europe, America and Asia.
Duties and Responsibilities:
" Maintain and improve the Quality Management System with working knowledge of ISO 13485, ISO 9001 and FDA 21 CFR Part 820.
" Lead on continuous improvement initiatives.
" Lead timely closure of Complaints, non-conformances and supplier non-conformance. Leading on the reporting and actions for these.
" Supporting the development of new product introduction and creation of technical files for both existing and new products.
" Support international regulatory submissions.
" External and internal auditing
" Lead on Risk Management requirements.
" Previous leadership responsibilities within Medical Device manufacturing within a Quality Assurance or Regulatory Affairs capacity.
" Medical Device knowledge of ISO 13485, 9001 and FDA requirements.
" Experienced in EU Medical Device product submissions and licence renewals and registrations to regulatory agencies.
" Technical file compilation
" Risk Management ISO 14971
" Certified as an Auditor in ISO13485 or ISO9001
" Lead Auditor qualified is desirable.
" Lean / Six Sigma experience
If you have experience in both Quality Assurance and Regulatory Affairs within Medical Devices and would be motivated to contribute at a time of improvement and growth this could be the role for you.
Please send your CV and contact James Powell of TXM Recruit.
("quality assurance" OR qa OR "Regulatory affairs" OR "ce mark" OR "ce marking" OR "technical files" OR "design dossier" OR 93/42 OR mdd OR "iso 13485" OR gmp)
TXM Recruit is an equal opportunities employer. If you have any specific requirements or require assistance or reasonable adjustments to be made for you during the selection process due to disability or long-term health condition, we will do our best to assist you.