Säffle: QA/RA ansvarig inom läkemedel/medicin

Job Description: 

You will work independently activities in the medical device industry. This position will consult, advice and project work will encompass product registration, defining regulatory strategies, dossier writing or review, participation and/or arrange meetings with our clients and/or notified bodies and governmental authorities. In addition, services rendered can include; Quality assurance, regulatory & clinical affairs or other relevant fields. As an QA/RA within the area Medical Devices, you will continuously anticipate on future and current relevant developments for our clients. Additionally, you will be responsible for organizing and coordinating projects independently with adequate communication and in full transparency to our clients. 

Competence requirements  Experience of minimum 3 years’ work within QA & RA area
Experience of writing Product Technical Files for medical devices
Trained auditor within MD standards: MDR, MDSAP, ISO13485, Quality System Regulation 21 CFR 820 and Health Canada Medical Devices Regulations (SOR/98-282)
Experience of building a Quality Management System, implement and follow-up
Experience of conduction risk analysis and follow-up of risk residuals
Experience of managing product developing projects
Experience of validation and revalidation
Experience of ISO 9001, FSSC 22000, ISO 14000 a merit
Senior management experience a merit