Compliance should make innovation possible, not slow it down.
ClariSure Life Sciences is a U.S.-based, globally capable quality, compliance, risk and intelligence firm serving medical device, pharmaceutical, biotechnology, diagnostics, combination product and digital health organizations.
Help regulated organizations transform complex requirements into practical, risk-based systems that protect patients, strengthen compliance, improve operations and support responsible innovation — and then help them run those systems.
A Life Sciences industry where quality and compliance are understood as engineering disciplines that enable products to reach patients — supported by intelligent technology, and always governed by accountable professionals.
Five principles we work by
Risk decides the sequence
Not every finding is urgent and not every gap is equal. We rank work by patient risk, compliance exposure and business impact — and we can defend the ranking.
Systems, not documents
A procedure nobody follows is a finding waiting to happen. We build what the organization can actually operate.
Execution is the deliverable
Assessments are the beginning of an engagement, not the end of one.
Evidence over assertion
If it cannot be traced, it cannot be defended. That applies to our clients’ quality records and to our own claims.
Accountability stays human
Technology can accelerate analysis. It cannot hold a regulatory obligation.
Elie Ghattas
Founder & Managing Principal
- Master of Business Administration, General Management — University of Phoenix
- BSc, Life Sciences / Microbiology — California Polytechnic State University, Pomona
- Certified Lead Auditor, ISO 9001 & ISO 13485 — BSI
- Certified Risk Management Specialist, ISO 14971 — AAMI
- MDSAP Appraisal Team Member
- Certified Master Project Manager (MPM)
Elie Ghattas is a global quality, regulatory compliance and risk governance executive with more than 25 years of leadership across Class II/III medical devices and sterile pharmaceutical manufacturing — including 17 years of executive responsibility at Johnson & Johnson MedTech.
He serves as Management Representative and EU MDR Article 15 Person Responsible for Regulatory Compliance, directing multi-site global quality management systems, post-market surveillance and health authority inspection readiness. He has led quality organizations of up to 48 professionals across multiple U.S. sites, with executive responsibility for quality strategy, governance and budget. His regulatory record includes four consecutive major FDA inspections and more than twenty Notified Body and MDSAP audits led to closure with zero observations.
Much of his work has centered on enterprise product risk management — architecting a centralized ISO 14971 risk system across eleven commercial portfolios, consolidating fragmented legacy hazard analyses into a single governed structure, and introducing AI-enabled risk evaluation. He built global escalation and field action governance for Class III devices, and directed the quality integration of three acquisitions into a global quality management system. Earlier, he led quality control operations for aseptic manufacturing and microbiology facilities supporting parenteral products, and established the corporate quality infrastructure for a sterile pharmaceutical manufacturing facility.
He founded ClariSure to make that level of capability available to organizations that need it for a project, a program or a period — without requiring them to build it permanently.
ClariSure Life Sciences is an independent organization, not affiliated with or endorsed by any current or former employer of its founder. Capabilities beyond the list above — including regulatory submissions, clinical and GCP, IEC 62304, cybersecurity and in-region regulatory expertise — are delivered through qualified Subject Matter Experts in the ClariSure Expert Network under ClariSure project governance.
Deep expertise. Flexible engagements. Meaningful projects.
ClariSure is building a curated network of independent Subject Matter Experts across the Life Sciences disciplines. This is not standard employment and it is not a résumé database: ClariSure holds the client relationship and governance; engagements are defined before you start; no member is displayed or named to a client without explicit permission; and applying commits you to nothing.
To apply, tell us who you are and where your expertise runs deepest — we review every application individually and respond either way.
Is the Expert Network employment?
Does ClariSure work outside the United States?
Is ClariSure affiliated with its founder’s employers?
Let’s solve the quality or compliance challenge standing in your way.
Tell us what you are dealing with. We will tell you honestly whether it is something ClariSure should take on, and what the path forward looks like.