לוח משרות דרושים מנהל רגולציה בתל אביב יפו, לחיפוש זה נמצאו 4 משרות, מתוכן 1 בלוח החם חינם!

Requirements:
Bachelors degree or nursing qualification is required. Scientific/health care field preferred
Minimum 2 years of experience in preparation, tracking and submission of studies involving investigative product, to Israeli ECs and MoH, at CRO, Sponsor pharmaceuticals companies
Well familiarized with the various local ECs requirements and submission processes
Excellent knowledge of the Israeli Ministry of health Guidelines and requirements, for Investigative product, genetic and advanced therapy study submissions
Maintains up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation
Adequate ICH-GCP knowledge
Requires strong attention to detail in composing and proofing materials
Able to establish priorities and meeting tight deadlines
Pro-active and problem-solving attitude
Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands with flexibility
Self-motivation, able to take initiative and work independently with minimal supervision
Able to proactively seek guidance when necessary
Team player, collaborative attitude, able to work with cross-functional teams
Excellent planning and organizational skills
Personal resilience, perseverance, energy and drive
Excellent written and verbal English and Hebrew communication skills
Mustbeabletoprofessionallyinteractandcommunicatewithboth internal and external professional groups
Demonstrated computer literacy, usage of MS Office software, web-based systems and databases. Ability and willingness to learn how to work on new systems.

Requirements:
BS/BA (or higher) in science or engineering program.
Minimum two (2) years experience in program management within the medical device industry.
Applicable experience in a GLP, cGMP and/or QSR environment a plus. General working knowledge of regulatory requirements for medical device developers and manufacturers and quality assurance concepts such as Design History File (DHF), Device Master Record (DMR), Standard Operating Procedures (SOPs), and other quality system documentation.
Proficient in Excel, MSWord, PowerPoint, Visio and electronic QMS.