Quality and Regulatory Specialist- Corrections and Removals

The Company
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.

Role Description
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.
 
Responsibilities
– 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.
 
Requirements
-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

Other Information
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.