Dedicated, highly qualified professional with more than 10 years of experience at mid level management position. Experience concentrated in Regulatory Affairs (both pharma and medical devices) with exposure to Clinical (CTA applications, GCP)/healthcare Compliance and Quality Assurance (GDP, FSCAs, complaint handling, SOP writing, QMS).
High potential, dedicated to achieving results and getting things done. Very succesfull in implementing new regulationas or corporate procedures at local company level.
Personal attributes: calm and stress resistant, strong communications skills (both written and verbal), strong interpersonal skills, high level of professionalism and integrity, well respected within company, both at local and international level, good training skills
Director Medical Affairs (also responsible for Healthcare Compliance)
Since July 2008
I am a senior professional with many years of experience in RAQA within the medical devices sector. My current position is coupled with multiple responsibilities, such as: reimbursement, product complaints and liability handling, implementation/maintenance of a quality system, SOP writing. Experience with GDP inspection In my role as compliance liaison officer I have gained experience with implementing a company’s global health care compliance program at local level and providing training to the local organisation, writing and presenting Needs Assessment Documents. One of the responsibilities that come with this role is providing day to day compliance advice to the local organisation in relation to the company’s health care compliance program. Over the years, I have gained experience also with training people I am a member of the senior management team of Biomet Belgium and I have a direct reporting line to the Vice President Benelux, Turkey, Dache. My skill level allows me to communicate with high level international professionals Specialties RA/QA, Reimbursement, Health Care Compliance, Anti-Corruption programs, getting things done, calm and stress resistant, strong communication skills (both written and verbal), high level of professionalism and integrity, well respected within company, both at local and international level, training Knowledgeable about: • Royal Decree of 18/3/1999 related to medical devices • Royal decree of 14/12/2006 (Royal Decree on drugs for human and veterinary use) • MDD 93/42/EEC • ISO 13485 • Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03) • Law of 25 March 1964 (Belgian Drug Law) • Good Distribution Practices for Drugs (Annex V of RD 14/12/2006) Personal attributes: •Ability to work on my own or as part of a team •Self‐motivated with excellent communication skills •Well organized and good planning abilities •Good eye for detail •Multi‐tasking
Head Regulatory Affairs Unit
January 2006 --- June 2008
- ensure compliance with the European regulatory framework for drug clinical trials
Regulatory Affairs Manager
July 2004 --- December 2005
Analytical thinkingAttention to detailCommunicativeCoordinationEfficiencyOrganizationProblem solvingResult OrientedSelf-confidenceTrust
Medical devicesAnalytical ChemistryCAPAChemistryCommunication SkillsEnglish LabtechnicianEnzyme-linked immunosorbent assay (ELISA)Ethics submission and approval processDrug regulatory authoritiesGCPMarketing approvalOrthopedicQuality Assurance (QA)Regulatory affairsUnderstanding of regulatory guidelinesSOPRegulatory submissions
Skills and Expertise
PhD in Pharmaceutical Sciences from Ghent University in 1994
Pharmacist in Pharmaceutical sciences from Ghent University in 1988