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)

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