Regulatory Affairs Manager

Regulatory Affairs Manager – Medical Devices

📍 Location: Yokneam Illit

🕒 Employment Type: Full-time

A global medical device company is seeking a Regulatory Affairs Manager. The role involves managing global regulatory processes for innovative medical devices, ensuring compliance with international regulations and standards.

Key Responsibilities:

• Develop and implement regulatory strategies for global commercialization and compliance.

• Prepare and submit regulatory documentation to authorities worldwide, including IDE/510K for USA (Class II) and Technical Documents/Design Dossier for CE Mark Approval (Class II and III).

• Conduct negotiations with regulatory authorities such as the FDA.

• Supervisory responsibilities over employees, including interviewing, hiring, training, performance appraisal, and problem resolution.

• Provide regulatory education to product development, marketing, and clinical groups.

• Perform Copy Review for internal and external documentation.

Job Requirements:

• Bachelor’s degree in Science (Physical/Biological) or equivalent and extensive training in Regulatory Affairs related to worldwide product approvals.

• Minimum of 5 years of experience in all aspects of Regulatory Affairs in the Medical Device Industry.

• Strong understanding of the Medical Device Industry, regulations, standards, and Quality principles.

• Extensive hands-on experience in product approval applications, crisis management (such as recalls), and FDA inspections.

• Strong negotiation skills with regulatory bodies worldwide.

• Ability to manage multiple priorities and communication (written and verbal).

This is an opportunity to join an innovative company in the medical device industry.