Regulatory Affairs Specialist

Regulatory Affairs Specialist

Global Medical Device Company – Yokneam

Hybrid: 3 days onsite, 2 days from home

We are seeking a 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.