Regulatory Compliance Specialist

Regulatory Compliance Lead - Medical Device

Location: Hybrid, The position involves working alternately in Caesarea and Yokneam, with additional flexibility to work from home.

Position Summary:

An innovative and growing company in the medical device industry is seeking a Regulatory Compliance Lead to oversee regulatory compliance processes and ensure audit readiness. This is a unique opportunity to lead internal and external audits, implement corrective actions, and work on global process integration within a small, dynamic team.

Key Responsibilities:

Host and manage Health Authority audits and inspections.

Develop and execute effective corrective action plans to address third-party audit findings and ensure timely closure of action items.

Oversee internal audit programs, including planning and execution, to ensure compliance with ISO, QSR/GMP, and FDA standards.

Drive organizational readiness for audits and promote a compliance-driven culture.

Collaborate with global teams to integrate compliance processes into existing management systems.

Conduct failure investigations and provide timely regulatory responses.

Identify and address quality risks proactively to protect the organization and its customers.

Provide training and guidance to strengthen internal expertise.

Ensure adherence to all relevant policies, regulations, and environmental, health, and safety standards.

Requirements:

Experience in regulatory compliance or quality management within the medical device industry.

Strong background in conducting and managing audits.

Knowledge of FDA regulations and experience with failure investigations.

Bachelor’s degree in a relevant field; regulatory certifications are a plus.

Excellent English communication skills, both written and verbal.

Project management experience is an advantage.