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SeniorFull-time
Salary Range
$78,731 - $106,519 /year
This salary is estimated based on similar roles. The actual salary may vary.
About the Role
We are seeking a Technical Lead to oversee the operational delivery of medical schemes, including MDR and IVDR conformity assessment activities under SGS NB 1639. This role ensures regulatory compliance and drives operational excellence in a global setting.
Key Responsibilities
- βLead and manage technical functions including clinical, auditors, and product assessors for all medical schemes globally
- βEnsure compliance with ISO 13485, MDSAP, UKCA, and EU MDR/EU IVDR requirements
- βManage technical certification activities, resource allocation, and process improvements
- βLead training and competence management strategies across technical teams
- βAct as key interface with regulatory authorities and internal stakeholders
- βMonitor regulatory changes and industry trends to adapt technical operations
- βManage impartiality and conflict of interest policies across all teams
- βProvide technical input to commercial business development and bid responses
Requirements
- βMinimum 10 years in the medical device or IVD industry
- βAt least 5 years of senior leadership in a Notified Body
- βMinimum 2 years in revenue-focused leadership roles with P&L accountability
- βQualification as Lead Auditor or Product Assessor under EU MDR/EU IVDR
- βQualification as Final Reviewer and Decision Maker under MDR or IVDR
- βUniversity degree in medicine, engineering, life sciences, or related field
- βFluency in English in addition to the local language
Benefits
- β Opportunity to work in a fully remote capacity across Europe
- β Potential for career growth within a global organization
- β Competitive compensation package (not specified)
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