The Company

Our client is a global leader in the healthcare sector, focusing on quality and compliance in medical devices and combination products. They are committed to maintaining the highest standards of safety and innovation, ensuring their products meet stringent regulatory requirements.
 

Role Description

The MDCP/ISO Senior Specialist will lead the ISO certification efforts and ensure new product launches comply with European and US FDA regulations. The role involves maintaining quality management systems (QMS) in line with ISO 13485 standards, conducting gap assessments, and hosting audits.
 

Responsibilities

– Lead ISO certification and support product launches for medical devices and combination products.
– Maintain QMS in compliance with ISO 13485 standards and conduct regulatory gap assessments.
– Collaborate with teams to implement corrective actions and prepare for Notified Bodies and FDA audits.
– Stay updated on regulatory changes and provide training on quality requirements.
– Participate in continuous improvement initiatives and process optimization efforts.
 

Requirements

– Minimum 5 years of experience in quality for medical devices or combination products.
– Strong knowledge of ISO 13485, 21 CFR Part 4, QMSR, and EU MDR.
– Experience in hosting audits by regulatory bodies like the FDA and Notified Bodies.
– Excellent leadership, communication, and project management skills.
– Ability to work in a fast-paced, dynamic environment.
 

Other Information

If you’re interested in this opportunity, please apply via the button so we can connect with you!

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