Director of Research & Development (R&D)

We are seeking an experienced and strategic Director of Research & Development (R&D) to lead innovation and product development in the healthcare and medical device industry. This role is responsible for driving the development of breakthrough technologies, ensuring regulatory compliance, and leading cross-functional teams to bring innovative medical solutions to market. The ideal candidate will have a strong background in Class I and Class II medical device development, regulatory frameworks (FDA, MDR, ISO 13485), and R&D leadership.

Key Responsibilities:

• Strategic Leadership: Develop and execute the R&D roadmap aligned with business objectives and market needs, focusing on Class I and Class II medical devices.
• Innovation & Product Development: Oversee the ideation, design, and development of next-generation Class I and II medical devices and healthcare technologies.
• Regulatory & Quality Compliance: Ensure compliance with regulatory requirements, including FDA 510(k), CE Mark, MDR, and ISO 13485. Collaborate with regulatory and quality teams to support submissions and audits.
• Cross-Functional Collaboration: Work closely with engineering, quality, regulatory, marketing, and contract manufacturing teams to streamline product development from concept to commercialization.
• Project Management: Establish and track project timelines, budgets, and deliverables while ensuring alignment with company goals.
• Technology Scouting & Partnerships: Identify emerging technologies, foster partnerships with research institutions, and evaluate potential acquisitions or licensing opportunities.
• Team Leadership & Development: Build a high-performing R&D team, fostering a culture of innovation, accountability, and collaboration.
• Risk Management: Assess technical and regulatory risks, implementing mitigation strategies to ensure project success.

• Education: Minimum Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Life Sciences, or a related field.
• Experience: Minimum 10+ years of experience in R&D leadership within the medical device or healthcare industry, specifically in Class I and II devices.
• Technical Expertise: Strong knowledge of Class I and II medical device design, biomaterials, manufacturing processes, and relevant regulatory pathways.
• Regulatory Knowledge: Experience with FDA 510(k), MDR, ISO 13485, and GMP requirements for Class I and II medical devices.
• Project & Budget Management: Proven track record in leading multiple projects within time and budget constraints.
• Leadership Skills: Demonstrated ability to lead cross-functional teams and drive innovative solutions.
• Communication & Problem-Solving: Strong analytical, decision-making, and communication skills.

Preferred Qualifications:

• Experience in med-surgical devices including: operating room, intensive care unit.
• Prior experience in leading R&D in a startup or high-growth environment.
• Knowledge of clinical trials, human factors engineering, and reimbursement strategies for Class I and II devices.