Quality & Regulatory – Corrections and Removal
In business for over 130 years, our client is a global leader in health technology, voted 'Best Medical Technology Company” 2020. Their portfolio is wide-ranging, ranging from Household items to personal care items, all the way to hearing & breathing solutions. This company prides themselves on their purpose, which has never changed: to improve people's lives with meaningful innovations.
As a pivotal player in the correction and removal process, you'll collaborate closely with teams spanning various functions. Your focus will be on implementing appropriate actions for distributed products, with paramount importance placed on safeguarding patient well-being, maintaining product excellence, and ensuring customer contentment.
– Assisting in executing post-market risk assessments, notably concentrating on Issue Impact Assessment
– Engaging proactively in multifaceted teams, leveraging your expertise to ensure seamless execution of tasks, including C&R and Risk Assessments
– Providing support in formulating precise responses to Regulatory agencies' inquiries and meticulously tracking ensuing actions
– Maintaining a vigilant watch on C&R progress, and furnishing regular, informed updates to IGT Systems C&R management and teams
– Serving as a recognized authority on Quality and Regulatory matters pertaining to the C&R process
– Bachelor's degree in a Technical Discipline, ideally connected with Healthcare, Engineering, or Science
– 6+ years' experience in a pertinent capacity within the medical device or regulated industry
– Proficiency in Project Management, with a minimum of 2 years of experience
– Familiarity with Quality management systems, coupled with an understanding of regulations encompassing 21 CFR Parts 803, 806, and 820, EU MDR, ISO 13485, ISO 14971, Canadian Medical Devices Regulation, and Japanese MHLW Ordinance 169.
Are you ready and would like to apply fot his position? Feel free to contact me or apply below.
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Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
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