Regulatory Affairs Specialist

Company Description

At Johnson & Johnson MedTech, we are dedicated to addressing the world’s critical healthcare challenges by innovating at the intersection of biology and technology. With expertise in surgery, orthopaedics, cardiovascular, and vision, we deliver solutions that are smarter, less invasive, and personalized. Our next-generation medical technologies are designed to tackle complex health issues and improve lives globally. We are committed to advancing healthcare through groundbreaking innovations that make a real-world impact.

Role Description

We are seeking a highly motivated Regulatory Affairs Specialist for a full-time hybrid role based in Nes Ziona with flexibility for some remote work. The Regulatory Affairs Specialist will be responsible for preparing and submitting regulatory documents, ensuring compliance with regional and global regulations, and interpreting regulatory requirements. This role involves collaborating with cross-functional teams to support the development, registration, and lifecycle management of innovative medical technologies.

Qualifications

Strong knowledge of Regulatory Documentation, including preparation and reviewing of technical files

Understanding of Regulatory Compliance and adherence to applicable standards, laws, and guidelines

Familiarity with Regulatory Requirements and global regulatory policies impacting medical technologies

Experience in Regulatory Affairs, particularly in the medical device or healthcare sector

Proficiency in preparing and managing Regulatory Submissions for product approvals

Excellent organizational and project management skills

Strong communication and collaboration abilities for cross-functional teamwork

Bachelor's degree in a relevant field such as Life Sciences, Engineering, or a related discipline

Previous experience in medical device regulation or healthcare technology is an advantage

Fluency in English is essential; additional language skills are a plus

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