VP R&D

We are seeking for a VP of R&D with a strong chemistry background and a proven track record of executive leadership in medical device startups.

This role requires significant experience in leading multidisciplinary teams (Chemistry, Biology, Engineering), managing development processes.

This position reports directly to the CEO

Key Responsibilities:

Strategic Leadership & Team Management

• Lead the development and execution of the company’s R&D strategy in alignment with business goals.
• Manage and mentor a multidisciplinary R&D organization, including Chemistry, Biology, and Engineering departments.
• Foster a culture of innovation, accountability, and cross-functional collaboration.
• Ensure effective professional guidance on DHF (Design History File) and product documentation processes.

Product Development & Scale-Up

• Oversee all product development phases—from early-stage research to full-scale product launch.
• Drive scale-up activities and ensure design transfer readiness to manufacturing partners.
• Ensure project timelines, resources, and budgets are aligned and well-managed.

Regulatory & Clinical Interface

• Partner with RA/QA to ensure compliance with regulatory requirements (FDA, CE, etc.).
• Support the submission of regulatory files, including 510(k)/PMA and related technical documentation.
• Collaborate with clinical teams and be actively involved in the design and execution of clinical studies.

Chemistry & Process Development

• Provide technical leadership and oversight on all chemistry-related activities, including formulation, process development, and cleanroom operations.
• Identify and address bottlenecks and ensure process robustness and reproducibility across sites.

Operations Oversight:

Oversee the company's operational activities to ensure alignment with R&D objectives and overall business goals. Collaborate closely with Operations, Production, and Quality teams to ensure efficient implementation of development plans, smooth scale-up processes, and readiness for commercial manufacturing. Drive operational excellence through cross-functional coordination and process optimization.

• Top of Form

External Partnerships

• Manage relationships with local and international subcontractors, academic partners, and consultants.
• Represent the R&D function in discussions with strategic partners, regulatory bodies, and clinical collaborators.

Requirements:

• PhD or MSc in Chemistry or related field.
• Minimum 10 years of R&D leadership experience in the medical device industry, preferably in startup environments.
• Demonstrated experience in managing multidisciplinary teams and taking products through regulatory approval and to market.
• Deep understanding of DHF, risk management, product file preparation, and relevant standards (ISO 13485, 21 CFR Part 820).
• Proven track record in working with external manufacturing and research partners.
• Excellent communication skills, both internally and with external stakeholders.