Regulatory Affairs Project Manager

📍 For comprehensive details about this opportunity and our company, as well as an additional open position, please visit our full job posting here:

https://www.linkedin.com/posts/dana-hait-0966a289_medicaldevices-qualityassurance-regulatoryaffairs-activity-7284177388614152194-PU3y?utm_source=share&utm_medium=member_desktop

About Us:

We are a growing medical device company in Yokneam developing innovative solutions for minimally invasive procedures. Our company focuses on advanced medical technologies that enhance physician capabilities and improve patient outcomes.

We are seeking a skilled and detail-oriented RA Project Manager to join our team. This role is ideal for individuals passionate about regulatory affairs and making an impact in the medical device industry.

LOCATION: Yokneam, Israel

SCOPE & RESPONSIBILITIES

• Preparing, coordinating, tracking, and following up on submissions for medical devices in various international markets
• Preparation and management of EU MDR technical documentation submissions
• Oversees CER, PMS, and PMCF activities, including customer complaints, vigilance, and recall
• Participate in regulatory inspections and audits
• Prepare regulatory assessments for design changes
• Developing labeling according to applicable regulatory requirements

REQUIREMENTS

• 2-7 years MANDATORY experience in medical device RA/QA engineering
• Biomedical Engineering / Biotechnology degree
• High-level proficiency in English (written and spoken)
• Excellent teamwork ability and interpersonal skills
• Service oriented mindset with attention to details
• Ability to work in dynamic and multi-interfaced surroundings, micro and macro vision
• Strong attention to details
• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint)