Beschreibung

In this role, you will lead the operational delivery of medical schemes, ensuring compliance and driving excellence across technical teams. Your day-to-day responsibilities will involve managing resources, fostering continuous improvement, and collaborating with regulatory bodies to uphold standards.

Anforderungen

• •Strong understanding of EU MDR, EU IVDR, UKCA, MDSAP, ISO13485 and MDD
• •Proven leadership in managing cross-functional teams in regulated environments
• •Knowledge of conformity assessment procedures and QMS requirements
• •Excellent interpersonal and stakeholder management skills
• •Strong organizational and change management capabilities
• •Strong commercial understanding of the TIC industry
• •Experience in resource planning
• •Qualification as Lead Auditor or Product Assessor under EU MDR/EU IVDR
• •Qualification as Final Reviewer and Decision Maker under MDR or IVDR
• •Experience in a Notified Body or equivalent regulatory organization
• •Minimum 10 years in the medical device or IVD industry, including design, manufacturing, auditing, or technical documentation assessment
• •At least 5 years senior leadership in a Notified Body managing technical employees
• •Minimum 2 years in revenue-focused leadership roles, including P&L accountability, budget management, and financial reporting
• •Demonstrated success in leading high-performing teams and driving operational efficiency
• •Fluency in English in addition to the local language
• •University degree in medicine, engineering, life sciences, or a related field

Aufgaben

• •Lead and manage global technical functions for medical schemes
• •Ensure compliance with ISO 13485, MDSAP, UKCA, and EU MDR / EU IVDR requirements
• •Oversee efficient allocation and utilization of technical resources
• •Manage operational technical certification activities and monitor KPIs
• •Develop training and competence management strategies for technical teams
• •Support recruitment, onboarding, and qualification of conformity assessment personnel
• •Drive continuous improvement of technical workflows and IT systems
• •Act as a key interface with regulatory authorities and accreditation bodies
• •Monitor and adapt to regulatory changes and industry trends
• •Manage impartiality and conflict of interest policies across teams
• •Ensure compliance with integrity policies, health & safety standards, and confidentiality
• •Foster a culture of client focus and continuous development within technical teams
• •Collaborate with Commercial & Delivery to align capacity with demand
• •Provide strategic input for designation maintenance and regulatory engagement
• •Offer technical input for commercial business development and bid responses
• •Support budget and KPI visibility for technical operations