Quality Assurance and Regulatory Affairs Specialist - Medical Devices

Responsibilities:

• Assist the Quality and Regulatory Affairs Manager in developing, implementing, maintaining the Quality management system to ISO 13485, MDSAP, QMSR/USA
• Manage quality processes, including document control, CAPAs, procedures, forms, nonconformance reports, complaints, supplier management and change controls, supplier Corrective actions
• Contribute to Risk Management to ISO 14971, Software Lifecyle to IEC 62304 and Design History file, Usability study and the clinical evaluations.
• Plan and conduct Internal Audits and Participate in internal and external audits, inspections, and investigations
• Interacting with Contract manufacturers on releasing the products /Device History records, labels, IFUs, Unique device identification and others
• Creating the Technical files to EU MDR, UK MDR 2002, registering the products worldwide, assisting in post- market activities and Manage EUDAMED
• Monitor relevant regulatory and standards changes and help assess their impact on our products and processes
• Takes responsibility for the day-to-day Quality Assurance and Regulatory Affairs activities. Experience required
• Experience ISO 13485 and medical device Technical documentation
• Previous experience working with medical device
• Good understanding of EU MDR requirements and applicable guidance/standards
• Ability to work independently and manage multiple technical files Minimum Qualifications
• Degree (or equivalent) in sciences, life sciences, engineering or quality management or others
• Internal Auditor experience and/or qualification. Desirable
• Experience in software as medical device and Design History File Essential
• 2 to + 3 years of experience within the Medical Device