VP Regulatory Affairs & Quality Assurance (VP RA/QA)

Company Description

An early commercial-stage medical device company that has recently initiated commercialization in the U.S. and EU, with plans to expand to additional global markets (ROW). Headquarters located in Caesarea Business Park, Israel

Role Description

The VP RA/QA leads global Regulatory Affairs and Quality Assurance activities, ensuring compliance with applicable regulations while supporting newly launched commercial operations and international expansion.

Key Responsibilities:

•           Maintain compliance with FDA requirements (21 CFR Part 820 and applicable updates), EU MDR, ISO 13485, and other relevant standards.

•           Manage regulatory submissions and approvals (e.g., 510(k), Technical Documentation, CE Mark maintenance, change notifications, renewals, and international registrations).

•           Oversee the Quality Management System (QMS), including CAPA, complaint handling, post-market surveillance, vigilance reporting, supplier quality, and risk management.

•           Manage the RA/QA organization in alignment with company growth.

•           Supervise the Quality Control (QC) team, including oversight of product release activities, incoming inspection, testing, and ongoing quality monitoring.

•           Lead regulatory inspections and quality audits; ensure inspection readiness.

•           Support product lifecycle management, including design controls and ECOs

•           Management representative and Interface with regulatory authorities, notified bodies, distributors, and commercial partners.

•           Provide regulatory and quality input to executive management and Board reporting as required.

Qualifications:

•           10+ years of regulatory and quality experience in medical devices, including leadership roles.

•           Demonstrated experience with FDA, MDR submissions, and compliance.

•           Ability to communicate clearly and effectively with FDA review teams, notified bodies, and other regulatory authorities, including leading formal meetings, written correspondence, and inspections

•           Great communication skills and team management

•           Full professional proficiency in English (written and verbal).

• •           Advanced degree in a scientific discipline (e.g., Engineering, Life Sciences, Pharmacy or related field) an advantage