Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist – Clinical Submissions

Global Medical Device Company – Yokneam

Hybrid: 3 days onsite | 2 days remote

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).

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.

Requirements

• Minimum 4 years of experience in Regulatory Affairs within the medical device industry (not pharma).
• 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.