n evaluating business processes, application landscapes, and regulatory compliance to drive digital transformation, risk mitigation, and modernization initiatives. The consultant will work closely with IT, business, and compliance stakeholders to ensure solutions align with MedTech regulatory and operational requirements.
Provide subject matter expertise on MedTech regulations, digital health, and compliance standards
Assess business processes, application usage, and system alignment with MedTech operational needs
Perform Application Portfolio Rationalization (APR) assessments across clinical, quality, and regulatory systems
Advise on modernization, consolidation, and digital transformation opportunities
Evaluate compliance readiness including 21 CFR Part 11, GxP, and define risk-based validation strategies (CSV/CSA)
Collaborate with IT, business, and compliance teams to ensure recommendations meet regulatory and business goals
Develop assessment documentation, cost-benefit analysis, and transformation roadmaps
Present findings and recommendations to senior stakeholders
Opportunity to work on strategic APR and digital transformation initiatives
Exposure to global MedTech regulatory and compliance landscapes
High-impact consulting role with senior stakeholders
Long-term engagement within a specialized MedTech practice
Collaborative, cross-functional work environment
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