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.