Project Manager (Position #7000)
Hod Hasharon, Israel
Full time
Job description
We are seeking a highly organized and proactive Project Manager to lead cross-functional initiatives from planning through execution. The ideal candidate will have strong leadership skills, proven project management experience, and the ability to deliver results within scope, budget, and timeline.
What You’ll Do
* Define project scope, goals, and deliverables in alignment with business objectives.
* Lead cross-functional teams and coordinate internal and external stakeholders
Identify, assess, and mitigate project risks.
* Collaborate with team leaders to define clear milestones and track progress against company goals.
* Track progress and prepare status reports for leadership and stakeholders.
* Ensure compliance with company policies, regulatory requirements, and industry best practices.
* Support preparation of documentation for regulatory milestones (e.g., ISO 13485 compliance, FDA 510(k), CE submissions).
* Partner with clinical teams to support study planning and execution.
Requirements:
Bachelor’s degree in business, engineering, or related field.
PMP® certification (required).
5+ years of project management experience, preferably in a medical device, biotech, or complex hardware & software products.
Strong knowledge of project management methodologies (Agile, Waterfall, or hybrid) and tools (e.g., Jira/Confluence, Smartsheet/MS Project, requirements and risk management tools).
Excellent communication, problem-solving, and leadership skills; fluent in Hebrew and English.
Familiarity with regulatory environments (FDA, CE marking, ISO 13485) and associated testing requirements.
Nice-to-Haves
Experience contributing to FDA 510(k) submissions or EU MDR interactions.
Familiarity with standards such as ISO 14971 (risk management), IEC 62304 (software lifecycle), IEC 62366 (usability), and ISO 10993 (biocompatibility).
Exposure to NPI/operations (supplier qualification, process validation, DFM/DFA).
Technical degree in engineering, computer science, or related field.
Experience with imaging/optics, AI/ML in regulated products, or dental devices/intraoral scanners.
Startup experience and comfort managing clear processes in fast-paced environments.
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