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.