Regulatory Affairs Specialist - Medical

A leading global medical device company in Yokneam is looking for a Regulatory Affairs Specialist to join our professional team.
Main Responsibilities:
Preparation of regulatory documentation for product registration and changes in international markets.
Collaboration with the RA core team to develop regulatory strategies.
Coordination and submission of regulatory documents to global authorities on behalf of our clients.
Managing regulatory correspondence for our clients.
Maintaining electronic communication tools such as SharePoint, regulatory databases, and client documentation libraries.
Communicating business-related regulatory matters to management.
Preparing for internal and external audits.
Ensuring compliance with federal, state, local, and corporate regulations, policies, and procedures.
Performing additional tasks as required.
דרישות התפקיד
Bachelor’s degree in Engineering, Life Sciences, Physics, or a related field, Master degree- Advantage.
3-4 years of experience in regulatory affairs, medical device industry.
Knowledge of FDA regulations and/or CE marking requirements (MDR).
Ability to work independently, as well as part of a team.
Leadership ability and Strong problem-solving skills , ability to identify and address process gaps.
Excellent verbal and written communication skills in both Hebrew and English.