Location: Anywhere in Belgium.
Travel: 30% maximun.
Reporting to: Global Business Manager - Healthcare and Medical Devices/IVD’s.
To lead the implimentation of the New MDD, measuring and analysing of gaps, compliance and continues improvement.
Integrated into the Medical Devices certification team, the Global Product Manager Medical Devices Regulations (EU) ensures that the certification services related to Medical Devices sold in the European Community under the new Regulations are successful and have long-term viability.
- To implement the new Medical Devices Regulation (MDR) within all Notified Bodies and the network
- To have overall responsibility for the successful management of the MDR ensuring the global operation is efficient and meets the expectations of internal customers (affiliates), external clients, scheme owners and accreditation bodies.
- To ensure global internal and external KPIs are met and all relevant approvals and accreditations are maintained to safeguard the business and reputation.
- To provide overall commercial strategy/guidance for affiliates to faciliate product growth in key countries and regions.
- To monitor market trends and track competitors' products to help improving the efficiency of the global business growth strategy.
Education and Requirements:
- Extensive knowledge and experience of the Medical Devices certification business and regulations.
- A minimum of 5-7 years quality assurance and auditing experience, preferably working for a Medical Devices certification body. Highly experienced candidates from Medical Devices Industry considered as well.
- University degree in a relevant technical subject (science, engineering)
- Fluent in English and preferably a regional language
CERTIFICATION / IVD / IVDR / MDD / MEDICAL DEVICES / ISO 13485 / AUDITOR / AUDITING / ASSESSOR / NB / CE / CE MARKING / TECHNICAL / REVIEWER / SPECIALIST / CLINICAL / BIOMEDICAL / MEDICAL / HEALTHCARE / SCIENTIFIC / ENGINEER / ENGINEERING / CERTIFICATION / NOTIFIED BODY / USA / UK / UNITED KINGDOM / EUROPE / Amsterdam, rotterdam, Eindhoven, Antwerp, Maastricht, leuven, breda, Alkmaar, Netherlands, Europe, drachten, Arnhem, Leeuwarden, Groningen, assen, leiden, holland, arnhem, nederland, Nijmegen / FRANCE, PARIS, MONACO, MONTPELLIER, PERPIGNAN, GRENOBLE, TOULON, TOULOUSE, LYON, DIJON, LILLE, BORDEAUX, ORLEANS LE MANS, NANTES, BREST, RENNES, LIMOGES, GENEVA, EUROPE, BRUSSELS, BELGIUM, GHENT / GENK / AUSTRIA / ANTWERP / BRUGES / MONS / LEUVEN / RENNES, CAEN, DIJON, MARSEILLE, CLERMONT, LA ROCHELLE, BREST, STRASBOURG, GRENOBLE, LUXEMBORG, GENEVA, CALAIS, AMIENS, VERSAILLES, ORLEANS, BOURGES, LE MANS, LE HARVE, LENS, VANNES, POITIERS, NIORT, MACON, DREUX, EVREUX, BEAUVAIS, COMPIEGNE, CHARTRES, BLOIS, TROYES, FECAMP, SENS / MUNICH, BERLIN, FRANKFURT, DUSSELDORF, MANNHEIM, BREMEN, BONN, HAMBURG, BREMEN, STUTTGART, DORTMUND,LEIPZIG,HANOVER,NURNBERG, LEVERKUSEN, FREIBURG, WOLFSBURG, HOFFENHEIM, AUGSBURG, NURNBERG, WIESBADEN, FURTH, COLOGNE, WURZBURG, Recklinghausen, DARMSTADT / MAINZ / HANAU / RHEIN / KOBLENZ / BUTZBACH / SAARBRUCKEN / METZ / HEIDELBERG / KARLSRUHE / BASEL / ESSEN / MUNSTER / BIELEFELD / LUXEMBURG / BRUNSWICK / WOLFSBURG / DRESDEN / CHEMNITZ / BAMBERG / ULM / ROSENHEIM / AUSTRIA / VEINNA / KOPENHAGEN / STOCKHOLM / ITALY/ROME/MILAN/PALERMO/SAN / MARINO/BOLOGNA/GENOA/MONACO/VENICE/VERONA/TURIN/NAPLES / SWISS / SWITZERLAND / GENEVA / BERN / ZURICH / LUSERNE / BIENNE / BASEL
- Medical Devices