Freelance Regulatory Affairs Specialist Medical Devices

Location: Israel (hybrid)

Contract duration: February-December 2025

Kelly FSP, on behalf of one of our top medical devices clients, is looking for Regulatory Affairs Specialist.

The Regulatory Specialist provide direct regulatory support to various projects focusing on existing products.

Responsibilities may include:

• Preparing regulatory registration, notification including the necessary regulatory documents.
• Providing regulatory support for product changes/modifications
• Supporting regulatory strategic planning and portfolio management
• Providing regulatory guidance to local business partners and liaising with RA teams
• Dealing with various local distributors for portfolio modifications
• Ensures compliance with regulatory agency regulations and interpretations.
• Prepares responses to regulatory agencies' questions and other correspondence.
• Prepares necessary outputs, including outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
• Provides solutions to a variety of problems of moderate scope or complexity.
• Conducts searches of existing files for requested information
• Maintains and archives all regulatory documentation.

Education and Experience Requirements:

• A minimum of a B.A. /B.S. within a technical-related discipline is required.
• Minimum of 1-3 years of experience in Regulatory Affairs or Master’s degree with equivalent experience
• Ability to work both independently and in a team environment.
• Ability to problem-solve, recognize, and find solutions for gaps in processes.