Skills & Abilites
- Extensive experience hosting regulatory inspections and interacting with regulators
- Strong understanding of global registration requirements and demonstrated trackrecord of successful market access.
- Experience with computer software validation (CSV) and implementation for QMSand ERP software packages, including user requirements gathering and specificationdevelopment, process workflow documentation, validation script writing, and IQ/OQ/PQ test case execution
- General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices
- Effective manager with ability to mentor and develop members of the QA/RAteams through coaching and effective performance management
Responsibility
- Proven ability to create culture of accountability and ownership
- Proven track record with establishing and maintaining strong internal and external partnerships.
- Must be able to work effectively at all levels in the organization in a matrix environment and with external partners.
- Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations.
- Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects.
- Highly independent and self-motivated and integrates well within a team. Physical Demands
- Ability to travel.