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Regulatory Affairs Manager
On-siteFull-timeRegulatory Affairs ManagementMedical Devices
Lead quality assurance and regulatory affairs for a medical device portfolio in Israel, ensuring regulatory compliance, quality system execution, market access, and business continuity.
Responsibilities
- Lead quality assurance and regulatory affairs activities for product registrations, renewals, variations, and lifecycle management in Israel
- Ensure compliance with Israeli regulations, internal policies, international standards, and quality management system requirements
- Act as the primary quality and regulatory affairs contact for the Israel market
- Coordinate regulatory submissions, technical documentation, health authority responses, and product maintenance activities
- Partner with commercial, operations, supply chain, legal, regional, and global stakeholders to support continuity and business objectives
- Monitor regulatory, quality, and enforcement changes and assess their impact on products and operations
- Support regulatory inspections, quality audits, and compliance assessments
- Drive continuous improvement, inspection readiness, and regional policy initiatives
Requirements
- Bachelor’s degree in regulatory affairs, life sciences, engineering, or a related discipline
- 6–8 years of progressive experience in quality assurance and/or regulatory affairs within medical devices, healthcare, or another regulated industry
- Strong knowledge of Israeli regulatory requirements and health authority processes
- Experience managing product registrations and lifecycle activities
- Ability to interpret and apply regulatory and quality requirements to product and business decisions
- Ability to manage multiple priorities in a complex, fast-paced, matrixed environment
- English language proficiency
Nice to have
- Advanced degree or professional certification in regulatory affairs or quality
- Experience supporting multi-country QARA portfolios
- Experience in a multinational or matrixed organization
- Exposure to regulatory inspections, quality audits, or health authority interactions
- Familiarity with EU MDR and related international regulatory frameworks
- Experience contributing to regulatory or quality process improvements
- RAC or equivalent certification
- Hebrew language skills
Benefits
- Inclusive work environment
- Limited occasional regional or international travel