The Company
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.
 
Role Description
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.
 
Responsibilities
– Assisting in executing post-market risk assessments, notably concentrating on Issue Impact Assessment
– Orchestrating the coordination of Health Hazard Evaluations in collaboration with Product technical specialists and Medical Affairs
– Engaging proactively in multifaceted teams, leveraging your expertise to ensure seamless execution of tasks, including C&R and Risk Assessments
– Steering the formulation of the C&R strategy, guaranteeing alignment with reporting requisites across diverse regions and overseeing its diligent execution
– 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
 
Requirements
– 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.
– A proactive, results-oriented mindset, underscored by an unwavering focus on quality and reliability.
 
Other Information
If you are interested in this job offer, please don’t hesitate to contact me for more information as soon as possible, or just click below to apply!