Leo Heller Email
Regulatory and Development Consultant @ MD squared B.V.
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Leo Heller Location
- Netherlands
Leo Heller Work
- Regulatory and Development Consultant @ (May 2024 - Present)
- senior Project Engineer R and D @ (December 2019 - April 2024)
- QA and RA manager @ (September 2019 - November 2019)
- Quality and Regulatory specialist @ (January 2019 - August 2019)
- Quality and Regulatory specialist @ Bioclin (Orange Pearl Innovation Group) (March 2018 - December 2018)
- Director of QA and Supply Chain @ Cassini BV (September 2016 - February 2018)
- Quality Assurance and Regulatory Affairs Manager @ i-Optics, EasyScan & Cassini (January 2012 - February 2018)
- Sr. QA Specialist @ (March 2010 - December 2011)
- Sr. Project Associate @ (January 2007 - December 2011)
- Quality Assurance and Regulatory Affairs Manager @ (October 2002 - December 2006)
- Business Process Redesign (thesis assignment) @ Elektromat bvba (January 2002 - September 2002)
- Mechanical Design Engineer (internship) @ Vitratron (a Medtronic company) (December 1996 - March 1997)
- Mechanical Engineer (internship) @ MRG (Medical Research Group) (August 1996 - November 1996)
Leo Heller Education
- Erasmus University Rotterdam
MSc. (Business Administration / drs. Bedrijfskunde - Innovation management)
1998-2006 - HU University of Applied Sciences Utrecht (Hogeschool Utrecht)
ing. (Fijnmechanische Techniek (FMT) / Bac. Precision Engineering)
1994-1998
Leo Heller Skills
- Quality Management
- Sterilization
- Design Control
- ISO 14971
- Verification And Validation V&V
- Computer System Validation
- GMP
- GAMP
- GxP
- Regulatory Affairs
- Change Control
- Life Sciences
- Validation
- Iso 9000
- Process Improvement
- Medical Devices
- Quality Assurance
- Corrective And Preventive Action Capa
- Quality System
- Research And Development R&D
- V&V
- Quality Auditing
- Change Management
- U.S. Food And Drug Administration Fda
- CE marking
- Project Management
- Pharmaceutical Industry
- CAPA
- FDA
- R&D
- Sop
- 21 CFR Part 11
- ISO 13485
- Corrective and Preventive Action
- u.s. Food and Drug Administration
- Research and Development
- Verification and Validation
Leo Heller Summary
- Leo Heller, based in Netherlands, is currently a Regulatory and Development Consultant at MD squared B.V.. Leo Heller brings experience from previous roles at Dutch Ophthalmic Research Center, Reboocon Bionics, BioClin, a Trimb Healthcare Group company and Bioclin (Orange Pearl Innovation Group). Leo Heller holds a 1998 - 2006 MSc. in Business Administration / drs. Bedrijfskunde - Innovation management @ Erasmus University Rotterdam. With a robust skill set that includes Quality Management, Sterilization, Design Control, ISO 14971, Verification And Validation V&V and more. Leo Heller has 2 emails on RocketReach.
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