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ZIMMER
- QARA Manager
Haifa
2012 - maintenant
: Regulatory & Quality Management Representative Benelux
Regulatory Affairs :
* Local Notification and Registration of products/instruments (medical devices / IVD)
* Safety incident reporting for Belgium and Luxemburg, The Netherlands
* Post market surveillance : Local notification of Incidents / Execution of Field Actions ;
* Management representative towards local health authorities in Belgium, The Netherlands and Luxemburg (for Regulatory Affairs), Nefemed (Dutch medical device industry representation),
* Healthcare Inspectorate Audit on Good Distribution Practice (GDP - GMP)
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Zimmer Biomet
- RA Manager
Haifa
2012 - maintenant
: ZIMMER BIOMET Orthopedics : Osteosyntesis & Biologics
: Quality Management & Regulatory Affairs Representative (team of 4 pax)
* Regulatory Affairs :
Follow-up of Notifications and Registration of products/instruments (MedDev, Pharma, IVD, Human Tissue)
Surveillance on Incident reporting for Belgium and Luxemburg, The Netherlands
Post market surveillance: Execution of Field Actions and FSN, Complaint Handling
GDP Responsible Person for pharma products (NL) & Medical Vigilance contact point
Management representative towards local health authorities in Belgium, The Netherlands and Luxemburg,
Pharma QPPV (NL) activities & Transfer of MAH due to merger
Healthcare Inspectorate Audit passed on application of Good Distribution Practices & local healthcare laws
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Medical device company
- RAQS Manager
2012 - maintenant
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SIEMENS Healthcare Diagnostics
- Regulatory & Quality Management Representative & Compliance Officer
2008 - 2012
: SIEMENS Healthcare Diagnostics (Dade Behring acquired)
Regulatory Affairs :
* Notification and re-registration of products/instruments (Class I-III IVDs) post acquisition due to name change / legal manufacturer changes (BE - Annex 10) ;
* Safety incident reporting for Belgium and Luxemburg (250/yr) ;
* Post market surveillance : FSCA - UFSN (40/yr) ;
* Management representative towards local health authorities in Belgium and Luxemburg (Regulatory Affairs), several meetings with EDMA (In-vitro Diagnostics EU Regulatory Affairs and Labeling task force), UNAMEC (be) - IVD medical device industry representation
* Several meetings with authorities on vigilance requirements and follow-up (WIV-ISP be)
* Supported Accreditation of Belgian laboratories (BELAC) - fulfilling accreditation requirements and questions from customers on quality and regulatory topics
* Solving local CE marking/Conformity inquiries/issues with Notified Bodies and customers
* Providing regulatory documents to customers and authorities on request (CE, DoC, CoA, IFU, etc)
* Support for application of Free Sales Certificates (export countries)
Quality Systems :
* Quality Management systems ISO 9001:2008 and ISO 13485 (medical devices) implementation and management representative ;
* Quality systems integration of 3 companies into 1 Siemens division - local certification audit leader
* Siemens Qualified Internal Quality Auditor (cross-sector healthcare, industry and energy)
* Local Responsible for CAPA-system and Complaint handling coordinator
* Organization of Quality Management review board meetings according to ISO 13485 and 9001
* Integration of Siemens DX, Diagnostics division into Siemens Corporate Quality System and Healthcare sector regulations
Environment, Health and Safety Manager :
* Follow-up of local safety and environmental requirements (3 different regions in Belgium + Luxemburg)
* Local environmental declarations (WEEE / Packaging waste / Batteries / Controlatom)
* Local setup of ISO 14000 EHS System
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SIEMENS Healthcare Diagnostics
- Regulatory & Quality Management Representative & Compliance Officer
2008 - 2012
: SIEMENS Healthcare Diagnostics (Dade Behring acquired)
Regulatory Affairs:
Notification and re-registration of IVD products/ Imaging instruments
Safety incident reporting for Belgium and Luxemburg
Post-market surveillance: Responsible for local FSCA - UFSN reporting and execution
Management representative for local health authorities in Belgium and Luxemburg
Representation (Regulatory Affairs Committees, EDMA (In-vitro Diagnostics EU Regulatory Affairs - Labeling task force), UNAMEC - IVD (medical device industry representation)
Several meetings with authorities on vigilance
Accreditation meetings of Belgian laboratories
CE marking investigations, etc...
Quality Systems:
Daily management of Quality Management systems according to ISO 9001:2008 and ISO 13485
Quality systems integration of 3 companies into 1 Siemens division - certification audit leader
Siemens cross-sector Qualified Internal Auditor,
Responsible for local CAPA-system maintenance and Complaint handling coordinator
Organization of Quality Management review board meetings
Integration of Siemens DX, the integrated Diagnostics division into Siemens Corporate Quality System and introduction of Siemens Healthcare sector regulations in Siemens HDX
Environment, Health and Safety Manager:
Environmental declarations
Setup of ISO 14000 EHS System
Responsible for integrated EHS system at local level: procedure setup, internal audits.
Other duties :
Local Compliance Officer (Business ethics) for Belgium and Luxemburg within Healthcare Sector, implementation of Siemens Compliance Program and business controls (Risk in Control process, SOA, SOX, LOA,...)
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DADE BEHRING SA
- Quality Systems Management representative & regional specialist
2006 - 2008
: DADE BEHRING SA (medical device - in-vitro diagnostics) :
Regulatory Affairs and Quality Systems Management representative, regional specialist, responsible for regulatory affairs, quality systems (ISO 13485 + ISO 9001) and environment, health and safety in Benelux and United Kingdom & Ireland sales organizations.
Regulatory package included :
* Responsible for follow-up of Regulatory Requirements in the region (Benelux/UK-Ire) and reporting to EU RA Management ;
* Regular contacts with local IVD and Competent Authorities on Vigilance ;
* Participation in local joint working parties from industry and competent authorities on common topics regarding evolutions in the field (eIFU-labeling, UDI, developments in IVD Directive, Vigilance follow-up, feedback on EU developments (eg EUDAMED) ;
* Responsible for Incident reporting and Notification of Field Actions in the region ;
* Representing DB at industry meetings regarding Quality and Regulatory locally (UNAMEC as well as internationally (EU- EDMA) ;
* Responsible person for registration of drug containing IVDs in Belgium (local psychotropic drugs registrations) with local authorities
* Working together with EU AR Representative in UK on EU legislation follow-up.
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DADE BEHRING SA
- Quality Systems Management representative & regional specialist
2006 - 2008
: DADE BEHRING SA (medical device - in-vitro diagnostics) :
Regulatory Affairs and Quality Systems Management representative, regional specialist, responsible for regulatory affairs, quality systems and environment, health and safety in sales and distribution
for Belgium, Luxemburg, The Netherlands, United Kingdom & Ireland (ISO 13485 + ISO 9001)
