שלח קורות חייםהוסף לסל
אינסייט השמה? Co-develop and execute clinical regulatory strategy for company product pipeline in the US, EU, China and ROW.
? Participate in planning regulatory milestones over the product lifecycle in coordination with cross-functional interdependencies.
? Serve as regulatory representative with other business partners and regulatory authorities such as FDA.
? Lead all regulatory aspects of clinical studies and product development, including design and review of clinical protocols and technical reports for adherence to regulatory guidelines.
? Manage and continuously improve company QMS, to ensure high quality development and manufacturing of company products.
Job Requirements:10+ years of direct clinical regulatory affairs and quality assurance experience within the Medical device, IVD, Biotech or Pharma industry ? B.A./B.Sc. in Life Sciences, Physical Sciences or Engineering (PhD – advantage) ? Experience with 510(K) and/or PMA submissions to the FDA ? Strong track record of managing and executing all regulatory and quality assurance aspects relating to clinical studies ? Deep understanding of ISO/FDA, QSR, IVDD, ISO 13485, ISO 15197, ISO 14971, IEC 62304, and ISO 60601 requirements. ? Proven track record in design and implementation of quality management systems in the medical device/IVD industry
? Experience with managing processes and inspections by notified bodies and other regulatory agencies
Required Experience:7 שנים ומעלה
Locations:מרכז, השרון, חיפה והקריות
Sub Categories:מחקרים קליניים, רגולציה, אבטחת איכות