Senior Regulatory Affairs Specialist – Clinical Submissions

We are seeking a Senior Regulatory Affairs Specialist with a strong focus on regulatory submissions to join a leading global medical device company. This role will lead regulatory activities supporting clinical investigations, including IDE, IRB/EC submissions, and collaborative clinical studies, for complex multidisciplinary medical devices (hardware, software, invasive technologies).
Location: Yokneam, Israel | Hybrid: 3 days onsite | 2 days remote

What You’ll Do:
-Lead and manage clinical regulatory submissions, including IDE submissions, IRB/EC applications, amendments, and ongoing study maintenance.
-Serve as the regulatory lead for US and EU clinical investigation activities, supporting first‑in‑human, feasibility, and pivotal studies.
-Prepare, review, and maintain clinical regulatory documentation, including protocols, Investigator’s Brochures, clinical risk sections, and regulatory responses.
-Support regulatory strategy development for clinical programs, ensuring alignment with development, clinical, and business objectives.
-Act as a primary regulatory interface with FDA and European regulatory bodies related to clinical studies.
-Collaborate closely with Clinical, R&D, Quality, Biostatistics, Operations, and external clinical partners/CROs.
-Participate in cross‑functional discussions supporting new product development and clinical evidence generation.
-Occasionally participate in evening calls with US‑based teams.
-Work in a hybrid model: 3 days in the Yokneam office, 2 days from home.
דרישות התפקיד:
-Minimum 4 years of experience in Regulatory Affairs within the medical device industry (not pharma) - must
-Hands‑on experience with clinical submissions (e.g., IDE, IRB/EC) is strongly preferred
-Experience with multidisciplinary medical devices (hardware, software, invasive systems)
-Strong understanding of US and EU clinical regulatory frameworks
-Proven ability to independently author and lead complex regulatory submissions
-Assertive, proactive, and capable of working independently in a fast‑paced environment
-Excellent command of English, written and spoken
-Motivation to grow and remain in the role for several years