Leaders in Pharmaceutical Business Intelligence (LPBI) Group

Orit Goldstein, BSc, MBA, Business Development – Medical Devices

 

2019 INACTIVE

 

 

Roles at Leaders in Pharmaceutical Business Intelligence

• Business Development for Telerescue Technology

http://www.telerescue.co.il/

• Expert, Author, Writer in the following research categories:

1.  CANCER BIOLOGY & Innovations in Cancer Therapy

2.  Bone Disease and Musculoskeletal Disease

3.  Coagulation Therapy and Internal Bleeding

4.  Ecosystems & Industrial Concentration in the Medical Device Sector

5.  Cardiac & Vascular Repair Tools Subsegment

6.  Frontiers in Cardiology

7.  Medical Devices

•    Stents & Tools.
•    Valves & Tools

8.  Procedures

•  Aortic Valve: TAVI, TAVI vs Open Heart Surgery
•  Mitral Valve: Repair and Replacement

9.  Nutrition

10. Origins of Cardiovascular Disease

11.  Stem Cells for Regenerative Medicine

 

Orit Goldstein

052-7322782

Oritgn@gmail.com

 

Education

Master of Business Administration, College of Management (2010)

B.Sc. in Biomedical Engineering, Ben-Gurion University (2008)

• Graduated with Honors

 

Professional Experience

2012 – Today      Project Manager, Mitralix

• Managed cardiac implant development project – from initial concept phase until V&V testing phase
• Developed company’s regulatory strategy
• Founded quality system infrastructure
• Owned design control activities
• Established production line with subcontractors
• Managed V&V activities – plan, protocols, set-up and execution
• Built and maintained Design History File (DHF)
• Documented pre-clinical reports and clinical plan

 

2012 – 2010        Project Manager, Medtronic Ventor

• Developed, tracked and communicated schedule for a strategic global project
• Integrated teams from Israel, Ireland and US
• Identified and managed project’s risks
• Developed and implement best practices among the team and the organization in the areas of PM, design and quality control
• Managed all pre-clinical efforts, working closely with institutions and physicians located in Israel, Europe and US

 

2008 – 2010          Project Manager, ReDent Nova

• Successfully led a dental device development project from product concept to market release including prototype builds, development and product validation
• Managed all work with project’s subcontractors, purchasing and inventory management as well as project logistics
• Prepared all engineering documents for submissions to CE Mark, FDA clearance, and Israeli Healthcare approval.
• Managed all aspects of transferring the project from product development to mass production

 

2008                   Pre-Clinical trials assistant, CorAssist

• Prepared and documented all animal trials for heart failure device

 

2008 – 2006        R&D Student, Initia Medical Technologies

• Planned and set up in-vitro and in-vivo tests for thermotherapy medical device

Military Service

Investigator in the intelligence corps (2001)

Language

Fluent in both Hebrew (mother tongue) and English