Director of Research & Development

We are looking for a proven R&D leader to drive the development of a highly advanced Class III medical devices through concept, preclinical, and clinical stages to FDA PMA approval.

The ideal candidate has deep expertise in design controls, system development, and design architecture, with hands-on experience managing GLP animal studies, clinical testing, and regulatory submissions.

This is a high-impact leadership role shaping next-generation life-sustaining technologies.

Position Summary :

• The Director of Research & Development will lead the design, development, and advancement of innovative Class III medical devices through all stages of the product lifecycle.
• This role is responsible for ensuring compliance with FDA regulations and global standards, driving R&D strategy, and managing cross-functional teams to deliver safe, effective, and commercially viable products.
• The ideal candidate will have deep expertise in design controls, system development, and design architecture, with a proven track record of successfully bringing FDA PMA devices through preclinical and clinical evaluation to approval.

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