RA project manager

RA Project Manager

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

• Degree in Biomedical Engineering or Biotechnology
• 2-5 years of relevant previous experience in regulatory affairs of medical devices
• 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).