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Quality Engineer – Development and Regulatory Affairs
HybridFull-timeRegulatory Affairs ManagementMedical Devices
A medical device company seeks an engineer to lead regulatory registration and documentation while contributing to quality processes and product development throughout the product lifecycle. The role is based at Bar-Lev Industrial Park, on-site with the option to work from home up to two days per.
Responsibilities
- Lead regulatory registration and documentation for medical devices.
- Prepare regulatory documents, protocols, reports, and technical documentation.
- Support new product development from concept through transfer to production.
- Participate in design reviews and design control throughout the product lifecycle.
- Ensure compliance with ISO 13485, FDA, and MDR/CE requirements.
- Maintain product files and engineering and regulatory documentation.
- Support engineering changes, regulatory updates, and regulatory events.
- Lead CAPA processes, non-conformance investigations, and root cause analysis.
- Collaborate with R&D, engineering, quality, regulatory affairs, and manufacturing teams.
Requirements
- Bachelor’s degree in engineering, life sciences, quality, or a related field.
- At least 2 years of quality and regulatory affairs experience in the medical device industry.
- Significant experience preparing, writing, and managing regulatory documents and protocols.
- Strong knowledge of ISO 13485, FDA, and MDR/CE requirements.
- Very high English proficiency in reading, writing, and speaking.
Nice to have
- Medical device product development experience.
- Experience with CAPA, risk analysis, and failure investigations.