Regulatory Affairs Program Lead

*Regulatory Affairs Program Lead* - Yokneam Illit, Israel | Hybrid

Company Description Radix Engineering specializes in turning complex engineering challenges into practical, end-to-end solutions that bridge product development and production.

Radix Engineering is recruiting on behalf of a leading global medical device company.

In this role, the Program Lead coordinates regulatory activities for engineering projects, ensuring compliance with relevant standards and regulations across the company’s target industries. Daily responsibilities include planning regulatory strategies, managing submissions and documentation, tracking approvals, and maintaining up-to-date knowledge of applicable regulatory frameworks. The Program Lead collaborates closely with engineering, quality, and project management teams to integrate regulatory requirements into product development and production processes. This role also involves monitoring regulatory risks, guiding internal stakeholders on best practices, and supporting continuous improvement of compliance processes and tools.

Key Responsibilities

• Develop, execute, and manage comprehensive regulatory strategies and pathways for innovative and modified medical devices.

• Lead the preparation and submission of complex FDA and international regulatory filings to support timely global market approvals.

• Ensure product development activities and clinical studies align with applicable regulatory requirements and business objectives.

• Serve as the primary regulatory interface with global regulatory authorities, including FDA, DEKRA, NMPA, and PMDA, as well as regional affiliates worldwide.

• Collaborate closely with cross-functional teams, including R&D, Clinical, Quality, and other key stakeholders, to support successful product development and commercialization.

Requirements

• Bachelor's degree or higher in a relevant scientific or engineering discipline.

• 6–8 years of Regulatory Affairs experience within the medical device industry (pharmaceutical experience is not applicable).

• Proven expertise in managing complex regulatory pathways and international regulatory submissions.

• Strong leadership skills, strategic thinking, and excellent communication abilities.

• Willingness and ability to travel internationally up to 10% of the time.

📩 To apply, please send your CV to: [email protected]