RA Project Manager
RA Project Manager
10/05/2022
A Global Medical Device company, developing and manufacturing medical device designed for neuro-interventions (located in Yokneam) is looking for a RA Project Manager.
As RA Project Manager, you will be responsible for new product submissions for regulatory approval in US, Europe, Japan, China, Brazil, Australia and more.
Scope & Responsibilities:
• Preparing, coordinating, tracking, and following up on approvals for medical device submissions in US (510k, Denovo), Japan, China, Brazil, Australia and more.
• Preparation and management of EU MDR technical documentation submissions.
• Oversees of CER, PMS and PMCF activities, including customer complaints, vigilance and recall.
• Participate in regulatory inspections and audits.
• Prepare regulatory assessments for design changes.
• Developing labelling according to applicable regulatory requirements.
Requirements:
• B.Sc. or above in Engineering or Life Sciences.
• Excellent English – experience in writing regulatory and clinical documents.
• Experienced in regulatory filings for US (510(k), IDE and de-novo), MDR 2017/745 and other key countries/regions.
• Experience in the Neurovascular field, an advantage.
• Ability to analyze and interpret standards, technical procedures, professional journals and governmental guidance and regulation documents.
• Eye for detail and accuracy.
• Experience working on multiple projects with aggressive timelines.
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