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.

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.