Regulatory Affairs & Quality Lead (Region Europe)
Core
Lead regulatory affairs and quality systems for medical device products across Europe, ensuring compliance with legislation and supporting safe product release.
Role type
Senior Regulatory Affairs & Quality Lead
Builds
Medical device products (precision radiation medicine)
Domain
Medical Devices / Radiation Therapy
Deliverable
client delivery
Required skills
Regulatory strategy, quality systems management, stakeholder influence, budget management, process improvement, team leadership, change management
Preferred skills
ISO Auditor certification, US FDA regulation knowledge, supplier quality experience, manufacturing engineering background
Technologies
Microsoft Office
Responsibilities
Coordinate regional regulatory submissions and maintain the regulatory roadmap; represent the company with regulatory bodies; establish and improve quality systems; approve documentation and ensure compliant product release; mentor team members; drive continuous improvement initiatives.
Seniority
Senior, hands-on IC with leadership responsibilities
