VP Clinical & Regulatory affairs

Job description:

• Driving the clinical strategy and regulatory compliance to bring our diagnostics products to market. Reporting directly to the CEO.
• Developing and managing global clinical trails to support regulatory clearance for a diagnostic product / IVD (including protocols, endpoints, CRO negotiations, etc)
• Developing global regulatory strategies and plans for In-Vitro Diagnostic (IVD) and CLIA/LDT products to achieve timely regulatory approvals (e.g. FDA pre-submission, breakthrough designation, etc).
• Leading communication and submission to regulatory authorities (FDA and CE Marking processes), Ethics Committees, Clinical Research Organizations (CROs), and clinical sites.
• Prepare and maintain regulatory documentation, timely submission, including product registrations, compliance reports, and technical files.
• Establish relationships with Key Opinion Leaders (KOLs), clinical sites, and research partners to support clinical trials and validation studies.
• Negotiate contracts and budgets with clinical sites.
• Work closely with the Product and R&D teams.

Qualifications:

• Advanced degree in life science fields
• 8+ years of experience in medical device regulatory affairs, with a strong focus on IVD products, preferably in early-stage startup environments.
• Proven experience managing FDA submissions, including clinical trials for IVDs
• In-depth understanding of the regulatory environment for IVDs, FDA, and international regulations (IVDR/MDR).
• Excellent written and verbal communication skills, with the ability to interact effectively with regulatory authorities and internal stakeholders.

Email for applications: [email protected]