Quality & Regulatory – Corrections and Removal

Location: Eindhoven, Noord-Brabant  |  Sector: Medical Devices  |  Start Date: 9/4/2023  |  Job ref: 51435

Quality & Regulatory – Corrections and Removal

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.



– 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.


Other Information

Are you ready and would like to apply fot his position? Feel free to contact me or apply below.


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About us

Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.

SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.

Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.

Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.