Regulatory Affairs Leader - Medical Device

Company Description

SYNC Projects specializes in Quality and regulatory affairs, focusing on regulations of Medical Devices and cosmetics. We work with the Israeli Ministry of Health, notified bodies in Israel and Europe, and manufacturing sites worldwide that produce a wide range of medical devices. The company offers a wide range of services, including quality standard certifications, CE marking, and Israeli Ministry of Health approval, among others. SYNC Projects prides itself on its values of integrity, professionalism, transparency, service, excellence, innovation, compliance, and leadership.

Role Description

The Medical Device Regulatory Affairs Leader is a full-time on-site role in Petah Tikva. The successful candidate will oversee medical device regulatory activities, ensuring the company's compliance with regulatory requirements, guidelines, and standards. The role involves managing cross-functional initiatives related to regulatory strategy, submissions, product development, and compliance.

Qualifications

• Bachelor's degree in a relevant field such as science, engineering, or healthcare.
• 2+ years of experience in regulatory affairs leadership roles in the medical device industry.
• Proven track record of successful regulatory submissions for complex medical devices.
• Experience managing regulatory approvals in various international markets, including US FDA and EU authorities.
• Excellent knowledge of global regulatory requirements and compliance standards for medical devices.
• Experience working cross-functionally with R&D, quality, legal, and clinical teams.
• Strong ability to communicate effectively with internal and external stakeholders and influence decision-making toward solutions that meet regulatory requirements and business goals.
• Ability to adapt quickly to changes and work in a fast-paced environment.
• Fluent in Hebrew and English, both written and spoken.