Required Regulatory Affairs Specialist.
Requirements:
Regulatory submissions: FDA, CE, Canada, advantage for more like: India, Japan, Korea, Taiwan, Brazil, Russia
Experience with Quality Management Systems in compliance with: EU Directives (MDD and MDR), FDA-QSR, ISO13485, Canadian MDR
Experience with international companies
knowledge in process reviewing (Process validations) including going through IQ,OQ PQ or process verifications and asses the suitability of the taken actions to the necessary situation, risks and standards
Experience in Internal external audits: FDA / CE / ISO Audits / MDSAP
Regulatory submissions: FDA, CE, Canada, advantage for more like: India, Japan, Korea, Taiwan, Brazil, Russia
Experience with Quality Management Systems in compliance with: EU Directives (MDD and MDR), FDA-QSR, ISO13485, Canadian MDR
Experience with international companies
knowledge in process reviewing (Process validations) including going through IQ,OQ PQ or process verifications and asses the suitability of the taken actions to the necessary situation, risks and standards
Experience in Internal external audits: FDA / CE / ISO Audits / MDSAP
Vast experience with:
o Risk management – ISO14971
o Labeling – EN 1041, ISO 15223
o Biocompatibility ISO 10993
o Usability EN 62366,
o Sterilization ISO 11737, ISO 11735, EN 14644
o Packaging / shelf life / Environment – transportation ISO 11607
Experience with UDI
maintenance of existing Technical files
This position is open to all candidates.
