Regulatory Affairs Specialist

Radix is seeking a talented and proactive Senior Regulatory Affairs Specialist – Clinical Submissions on behalf of our client, a leading global medical device corporation.

If you have a strong passion for clinical regulatory frameworks and want to lead submissions for complex, cutting-edge multidisciplinary medical devices (hardware, software, and invasive systems), this is the role for you!

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.
• Act as a primary regulatory interface with the FDA and European regulatory bodies related to clinical studies.
• Collaborate closely with cross‑functional leadership teams, including Clinical, R&D, Quality, Biostatistics, Operations, and external CROs.

What We Are Looking For:

• Minimum 4 years of experience in Regulatory Affairs within the medical device industry (not pharma).
• Hands‑on experience with clinical submissions (such as IDE, IRB/EC) is strongly preferred.
• Experience with multidisciplinary medical devices involving hardware, software, and invasive technologies.
• Strong, up-to-date understanding of US and EU clinical regulatory frameworks.
• Proven ability to independently author and lead complex regulatory submissions.

📍 Location: Yokneam area

💼 Model: Hybrid (3 days onsite, 2 days remote)