Location: Yokneam
Work arrangement: Hybrid
Job description
This role is responsible for managing and leading global regulatory processes, including preparing documentation, submitting filings to regulatory authorities, and supporting compliance with international standards and policies.
Key responsibilities
- Prepare regulatory documentation for product registrations and change submissions in international markets
- Collaborate with the core regulatory team to develop regulatory strategies
- Coordinate and submit regulatory dossiers to authorities worldwide on behalf of the company’s customers
- Manage regulatory correspondence for customers
- Maintain electronic tools such as SharePoint, regulatory databases, and customer document libraries
- Report regulatory topics and business-related updates to management
- Support readiness for internal and external audits
- Ensure compliance with federal, state, local, and organizational regulatory requirements, policies, and procedures
- Perform additional tasks as needed
Requirements
- BSc in Engineering, Life Sciences, Physics, or another relevant field – MSc is an advantage
- 3 to 4 years of regulatory experience in the medical device industry
- Knowledge of FDA regulations and or CE marking requirements (MDR)
- Ability to work independently and as part of a team
- Leadership capability, strong problem-solving skills, and the ability to identify and address process gaps
- Excellent Hebrew and English, written and spoken