Regulatory Affairs 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
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:
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)
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)
This position is open to all candidates.
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