Regulatory Affairs Specialist

Regulatory Affairs Specialist – Medical Devices

📍 Location: Yokneam Illit | 🕒 Full-Time Position

A global medical device company is seeking a talented Regulatory Affairs Specialist to join its team and take part in managing regulatory processes for cutting-edge medical device solutions across international markets.

Key Responsibilities:

• Manage product registration processes and regulatory changes in global markets.
• Develop and implement regulatory strategies in collaboration with the RA team.
• Prepare and submit regulatory documentation to international health authorities.
• Manage regulatory communications with clients and regulatory bodies.
• Maintain and update regulatory databases, document management systems, and digital tools.
• Prepare for and support internal and external regulatory audits.
• Ensure compliance with relevant regulations and internal procedures.

Requirements:

• Bachelor’s degree in Engineering, Physical Sciences, or Biology.
• 2-4 years of experience in regulatory affairs, preferably in the medical device industry.
• In-depth knowledge of FDA regulations and/or CE Marking requirements.
• Strong analytical, problem-solving, and project management skills.
• Excellent communication skills in both Hebrew and English.
• Proficiency in MS Office and SharePoint.

This is a great opportunity to join a dynamic and innovative company and contribute to the development of advanced solutions in the medical device industry.