The Company
Our client is a technology company, focused on improving people’s lives through meaningful innovations. With a century of history and more than 450 innovative products and services, their aim is to meet today’s healthcare challenges through technology.
 
Role Description
As a Norm Compliance Officer for IGT Systems, you are responsible for ensuring that the company’s Image-Guided Therapy (IGT) systems comply with applicable norms, standards, and regulations. You play a crucial role in maintaining regulatory compliance for medical devices, particularly within the framework of global healthcare regulations such as ISO standards, FDA requirements, and the Medical Device Regulation (MDR) in the EU.

Responsibilities
– Ensure adherence to industry standards, monitor regulatory changes and be the POC for  regulatory bodies
– Collaborate with R&D, quality, and engineering teams to ensure that products are designed and developed according to the applicable standards and norms from the start
– Contributes to the product approval process by supporting the certification of new products and assisting with product updates
 
Requirements
–  Degree in a technical discipline or health sciences, along with 3-5 years working in software or hardware testing/engineering roles 
– Experience in the global medical device sector, with knowledge of safety regulations such as IEC 60601 and familiarity with international compliance standards
– Strong abilities in project management and experience in leading process improvements or conducting audits 
– Strong team collaborator capable of positively impacting project outcomes

Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
 
 

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