Regulatory Project Manager - 770

Medinol is hiring a Regulatory Project Manager !

Key duties of the job:

• Support global and regional regulatory activities
• Prepare and manage various submissions and correspondence to regulatory authorities ensuring adherence to national and international regulations and standards (e.g. FDA, Health Canada, European Union and Asia)

Qualifications and training required:

• Minimum of a Bachelor’s degree in a Science discipline is required – life science, biochemistry, pharmacy or chemistry preferred.
• Work Experience: minimum of 7 years of regulatory affairs in medical device/pharmaceutical drug development, preferably 2-3 years CMC experience.
• Demonstrable experience in successfully developing and managing regulatory submissions.
• Prior experience with the preparation of CMC sections for regulatory submissions, as well as experience in registration of Device-Drug Combination Products (Class III) is highly desirable.
• Knowledgeable in FDA, EU, and/or Global regulatory submission processes is desirable.
• Exceptional organizational skills, ability to multi-task and be detail oriented.
• Ability to work well under pressure / Time management skills.
• English - mother tongue level/high proficiency ONLY

About the company…

Medinol is dedicated to the science of cardiovascular intervention. For over 25 years, we have delivered over two million coronary stents to patients worldwide. Our products constantly stretch the limits of innovation and our cutting-edge technology continues to demonstrate extraordinary clinical results. We make our products in-house using proprietary manufacturing technologies that ensure consistently exceptional quality and safety. Medinol manufactures EluNIR™, the first elastomeric drug eluting stent. Now FDA approved and CE marked, EluNIR demonstrated excellent clinical outcomes and promising safety profile in two clinical studies and features the Flexx² catheter technology with a metallic spring-tip, resulting in unprecedented ease-of-delivery even in tough anatomies. A unique stent design provides low metal footprint and optimized vessel support, leveraged by an elastomeric coating that ensures excellent surface quality. Founded in 1992 by Dr. Judith Richter and Dr. Kobi Richter and privately held to this day, Medinol continues to benefit from the leadership and insight of its founders. With more than 300 employees on board, we proudly maintain our family spirit and entrepreneurial culture.