Quality and Regulatory Specialist- Corrections and Removals
Our client is a multinational medical conglomerate whose innovations are driven by consumer and customer needs. Helping people to live healthily and prevent disease. Giving clinicians the tools, they need to make a precision diagnosis and deliver personalised treatment.
Your role as a Corrections and Removals Specialist is to make sure that appropriate actions are taken on distributed products, ensuring safety, product quality and customer satisfaction.
– Manage and be a line of support for the execution of risk- assessments or the Issue Impact Assessment.
– Lead the preparation of Health Hazard Evaluation together with the Product Technical Experts and Medical Affairs.
– Create all documentation for all C&R related files, making sure that the records meet the Good Documentation Practices.
– Generate all C&R related Customer Notifications and submit C&R Regulatory reports.
-Has Bachelor’s degree in Technical Discipline in Healthcare, Engineering or Science.
-Has 6 years of related experience in medical device or regulated industry preferably in Correction and Removal processes, regulatory submission, and Risk Management
– In-depth knowledge of Quality management systems and deep understanding of related regulation (e.g. 21 CFR Parts 803, 806, and 820, EU MDR – Regulation (EU) 2017/745, ISO 13485, ISO 14971, Canadian Medical Devices Regulation (SOR/98-282), and Japanese MHLW Ordinance 169). Proven work experience is preferable.
– Project Management experience is a plus
If you think this role is for you and you want to explore more of the possibilities, please contact Leri Salve Lapore and apply via the button below.
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