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Gsap מחפשת מנהל/ת פרויקטים ברגולציה- מכשור רפואי

Requirements for Gsap Medical Device Regulation Project Manager:

Knowledge and experience of at least 5 years communicating with the FDA, NB and other regulatory authorities

Native English or English at mother tongue level: Read, write and speak. Good understanding of the legal wording in the documents of the regulatory authorities and the practical implications of this wording.

Proven experience in handling regulatory issues and problems (such as, but not limited to classification)

Knowledge and experience in the effective search for an appropriate predicate in the FDA database

Knowledge and experience with the bureaucratic requirements related to 510(k) submission and pre-submissions

An engineering background that enables good technical understanding of how the product works and how it is used

Knowledge and experience in dealing with engineering changes at product level and with communication on Engineering changes with regulatory authorities.

Flexibility, creativity, fast and logical thinking, ability to draw analogs, ability to distinguish between "what is important" and "what is not important"

Good understanding of the requirements of the quality management system according to (at least) ISO 13485:2016, 21CFR820, MDR

High capabilities to read multiple documents for long hours and draw conclusions

Preference for a degree in Life Sciences and / Engineering / Biology / Physics / Software / Electronics – lawyers with technical background are also possible candidates

Knowledge and ability to clarify issues with experts regarding validation testing: Sterilization, Cleaning, Usability, Shelf life, Biocompatibility, Chemical characterization, Preclinical, clinical trials

  

בג'יסאפ מובילים תהליכים שמשפיעים על עולם הרפואה. מטרתנו היא להביא את התרופה או המכשיר הרפואי האיכותי ביותר אל המטופל במהירות הגבוהה ביותר.

בכדי להשיג זאת אנו פועלים לאורם  של  ערכי החברה, אותם אנו מחפשים בך: מקצועיות, אחריות, ניהול, התלהבות, שותפות ואימפקט רב מערכתי.  אם יש לך אותם, והגעת עד לכאן, אז שלח קורות חיים למייל: dianak@gsap.co.il