Head of Quality Assurance

Head of Quality and Regulatory

Location : Baden-Württemberg

Job Type : Full time permanent

Product : Cardiovascular Class III Implantable

Join a dynamic cardiovascular medical device company at the forefront of life-saving implantable technology. We are seeking an exceptional leader to establish and lead our Quality and Regulatory functions as we scale our operations across European and US markets.

Position Summary

The Head of Quality and Regulatory will be responsible for building and leading a world-class quality and regulatory organisation from the ground up. This is a unique opportunity to shape the regulatory strategy and quality systems for cutting-edge Class III cardiovascular implantable devices while ensuring compliance across multiple global markets.

Responsibilities :

• Develop and execute comprehensive quality and regulatory strategies for Class III cardiovascular implantable devices
• Establish scalable processes and systems to support rapid growth
• Partner with executive leadership to drive business objectives while maintaining regulatory compliance
• Lead regulatory submissions and approvals for both European (MDR) and US (FDA) markets
• Develop and maintain regulatory strategies for pre-market and post-market activities
• Manage relationships with regulatory authorities including FDA, Notified Bodies, and other global agencies
• Ensure compliance with evolving regulatory landscapes and standards
• Maintain robust QMS compliant with ISO 13485, FDA QSR, and EU MDR
• Develop and implement quality policies, procedures, and work instructions
• Lead risk management activities in accordance with ISO 14971
• Oversee design controls, validation, and verification activities
• Manage supplier quality and vendor qualification programs
• Drive continuous improvement initiatives and quality metrics

Requirements :

Technical Expertise

Please reach out to emily.james@skillsalliance.com for further information.