Topia MedTech
Quality Assurance and Regulatory Affairs Specialist - Medical Devices
Welwyn Garden City
Posted 1 day ago
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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 Lifecycle 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.
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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.
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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.
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