IVD Clinical Strategy Consultant – Global Consultancy
Location: Flexible / Remote (Global Projects)
Employment Type: Full-time
Are you an experienced IVD (In Vitro Diagnostics) specialist with a strong background in clinical trial design, execution, and regulatory strategy?
Our global consultancy client is expanding its regulatory and clinical team and is seeking an expert to lead all clinical aspects for IVD clients, supporting them from strategy through to regulatory submission.
Key Responsibilities
* Take the lead on clinical strategy and operations for IVD companies, from feasibility to post-market activities.
* Develop and implement clinical performance study strategies in line with IVDR and FDA requirements.
* Provide expert input on study design, regulatory pathways, and data generation strategies for global submissions.
* Collaborate cross-functionally with regulatory, quality, and scientific teams to deliver comprehensive consultancy support.
* Advise clients on compliance with IVDR Annex XIII, FDA 21 CFR 809, and applicable global clinical regulations.
* Support gap assessments, risk management, and remediation strategies for transitioning from IVDD to IVDR compliance.
Requirements
* Strong experience within the In Vitro Diagnostics (IVD) industry.
* Proven track record of leading clinical trial strategy and execution for IVD products.
* In-depth knowledge of IVDR (EU 2017/746) and FDA regulatory requirements for IVDs.
* Demonstrated ability to provide strategic consultancy and client-facing leadership.
* Background in clinical affairs, regulatory strategy, or related consultancy highly desirable.
* Excellent communication and stakeholder management skills.
Why Join Us
* Work with a global consultancy supporting top-tier diagnostics and medtech clients.
* Opportunity to lead high-impact clinical and regulatory projects shaping the future of diagnostics.
* Collaborative, international environment with flexibility and career growth.
If you’re an IVD expert with the confidence and experience to lead clinical strategy at a global level, we’d love to hear from you.
Apply now or reach out directly for a confidential discussion.