Senior Regulatory Affairs Specialist

1. Senior Regulatory Affairs Specialist
2. RA Clinical Submissions

Global Medical Device Company – Yokneam

Hybrid: 3 days onsite | 2 days remote

Senior Regulatory Affairs Specialist & RA Clinical Submissions

Global Medical Device Company – Yokneam

Hybrid: 3 days onsite, 2 days from home

We are seeking a *Senior Regulatory Affairs Specialist* to join a leading global medical device company. This role includes ownership of regulatory submissions, technical documentation, and change management within multidisciplinary systems involving hardware, software, and invasive medical technologies.--

*What You’ll Do*

* Lead end-to-end regulatory submissions, including technical documentation, change submissions, and authoring regulatory files for global markets.

* Manage regulatory aspects of design and manufacturing changes, including impact assessments on global approvals.

* Develop regulatory strategies for the US and EU markets.

* Collaborate directly with regulatory authorities, including regular interactions with US (FDA) and European agencies.

* Work closely with internal cross-functional teams—R&D, Operations, Quality, Engineering—as well as external partners.

* Participate in discussions with development and operations teams regarding new products and ongoing changes.

* 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 in the medical device industry* (not pharma).

* Experience with multidisciplinary systems (hardware, software, invasive devices).

* Strong independent work style, fast execution, and assertiveness.

* Excellent command of English—both written and spoken.

* Proven experience in authoring technical regulatory documents and leading submissions.

* Motivation to grow and remain in the role for several years.

We are also seeking a Senior Regulatory Affairs Specialist with a strong focus on Clinical 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.