Regulatory Affairs and Quality Specialist

As a Regulatory Affairs and Quality Specialist, you will play a pivotal role in ensuring our company's adherence to global quality standards and regulations. You will be responsible for maintaining our Quality Management System (QMS) and overseeing product registration processes worldwide.

Key Responsibilities:

• Oversee and maintain the company's QMS, ensuring compliance with FDA 21 CFR Part 820, European Medical Device Regulation (MDR), ISO 13485, ISO 62304, and ISO 14971 standards.
• Participate in product registration and regulatory approval processes for our medical devices in various global markets.
• Prepare and submit regulatory documentation, such as CE technical files.
• Collaborate with cross-functional teams to ensure product quality and regulatory compliance.

Qualifications:

• Bachelor's degree in engineering or a related scientific field.
• 3-5 years of experience in Quality Assurance within a medical device company, with a proven track record of implementing and maintaining QMS systems.
• 2-3 years of experience in Regulatory Affairs, with a strong understanding of US, European, Israeli AMAR, and international medical device regulations.
• Excellent written and verbal communication skills in Hebrew and English.
• Experience in preparing regulatory submissions (e.g., CE technical files) is a plus.
• Certified Auditor is a preferred qualification.
• Ability to thrive in a fast-paced startup environment.
• Strong organizational skills and the ability to multitask effectively.
• Detail-oriented and results-driven.
• Excellent communication and interpersonal skills.
• Self-motivated and able to manage priorities.
• Experience in a manufacturing medical device company is beneficial.

Join our team and make a significant impact on the healthcare industry.

It's not Hybrid!

Mail To : [email protected]

No 679886