Florence De Groot Email & Phone Number

Bilthoven, Utrecht, Netherlands

Bilthoven, Utrecht, Netherlands

Bilthoven, Utrecht Province, Netherlands

Product design, changes, extension, regulatory approvals, life-cycle, pre and post-marketing follow up studies, MDR transition, post-marketing surveillance of company's medical devices.Management of company's project leaders and product developement team.

Bilthoven, The Netherlands

Bilthoven (The Netherlands)Project manager for the design and development control of 4 implantable medical devices (class III) to obtain CE mark and 510k clearance for global market launch in collaboration with international leaders (Swiss, US) in the spine and maxillo-facial industry (>300 employees each);Leader of the Product Development team up to 5 members from technician to post-doc level (formulation, characterization, in vivo, biocompatibility, packaging, sterilization… Show more Bilthoven (The Netherlands)Project manager for the design and development control of 4 implantable medical devices (class III) to obtain CE mark and 510k clearance for global market launch in collaboration with international leaders (Swiss, US) in the spine and maxillo-facial industry (>300 employees each);Leader of the Product Development team up to 5 members from technician to post-doc level (formulation, characterization, in vivo, biocompatibility, packaging, sterilization, shelf-life testing, up-scaling)Owner of 3 Device History Files (class III Medical Device) dealing with Regulatory Authorities (FDA, DEKRA) for regulatory submission and conformity compliance. Main achievements • Obtained CE marking for 2 products sold in EU and oUS. • Established 3 GMP manufacturing processes onsite and at contract manufacturer• Applied 3 PCT patents for 3 novel technologies Show less

Project manager in charge for the development and 510k clearance of 1 implantable medical devices (combination product) in compliance with a licensed contract. Coordinating activities with the core team. Responsible for project milestones in front of the company’s management team. Performing R&D activities (formulation, characterization, in vivo, biocompatibility, packaging, sterilization, shelf-life testing, up-scaling) and coordinating activities with core teamSupporting business… Show more Project manager in charge for the development and 510k clearance of 1 implantable medical devices (combination product) in compliance with a licensed contract. Coordinating activities with the core team. Responsible for project milestones in front of the company’s management team. Performing R&D activities (formulation, characterization, in vivo, biocompatibility, packaging, sterilization, shelf-life testing, up-scaling) and coordinating activities with core teamSupporting business development activities: project value assessment, setting-up a Key Opinion Leaders board with 10 US clinicians;Identification, contacting and setting-up agreements with external partners (contract research organizations, suppliers, contract manufacturers) for company’s products.Main achievements • Obtained budget from Board of Directors to develop a new product for the US market. • Validated the product’s value with a board of 10 US key opinion leaders.• Selected and secured critical manufacturers (supply, contract manufacturing) for 3 products. Show less

Regenerative Medicine Department, Enschede (The Netherlands)

Research project management on cell-material interactions, recruitment and leadership of students (master’s and PhD candidates)Main achievements• Obtained Veni grant from the Dutch Foundation of Science and Technology (STW, 2005);• Obtained FP6 Marie Curie EST grant (JOIN(ed)T, 9 partners, 2006)• Successfully applied newly learned techniques on cell culture and characterizations

Applied research project management on protein biopolymers.Main achievements:• Successfully applied newly learned techniques on protein characterization

Bilthoven, The Netherlands

Research project management « Biomimetic calcium phosphate coatings: physico-chemistry and biological activity» in collaborations with 2 orthopeadic prostheses companies (Implex Corp. USA and Stratec Medical AG, Switzerland) and 2 academic hospitals (Utrecht and Maastricht).Main achievement :• Contributed to CE marking of CreatOs® for Stratec Medical AG (CE mark in 1999).• Successfully applied Quality Policy for conducting research according to GLP guidelines.• Defended my… Show more Research project management « Biomimetic calcium phosphate coatings: physico-chemistry and biological activity» in collaborations with 2 orthopeadic prostheses companies (Implex Corp. USA and Stratec Medical AG, Switzerland) and 2 academic hospitals (Utrecht and Maastricht).Main achievement :• Contributed to CE marking of CreatOs® for Stratec Medical AG (CE mark in 1999).• Successfully applied Quality Policy for conducting research according to GLP guidelines.• Defended my PhD based on the research and obtained results. Show less

Phd, Biomedical Engineering

Thèse (2002) "Biomimetic calcium phosphate coatings: physico-chemical and biological activity", ayant abouti à publications (Biomaterials.

Master'S Degree, Science Des Matériaux

*Stage sur la préparation de phosphates de vanadium par procédés sol-gel

Education record

Education record

Education record