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NB Technical Manager - Medical Devices - Belgium

NB Technical Manager - Medical Devices - Belgium

Posted 13 August by Bosch Global Associates Ltd
Easy Apply Ended

Salary: Negotiable 80-100k Eur

Type: Permanent.

Location: Belgium / Europe


Job description:


• To provide technical support to the network on Regulations and Certification procedures
• To contribute in the day-to-day management of the Medical Devices activities to achieve defined operational and financial targets and maintain both technical and regulatory compliance
• To provide expert regulatory and technical support at all stages of the medical device conformity assessment process to the network;
• To undertake PWS (Product Work Sheet) approval and audit team allocation activities related to medical device conformity assessment process for the network in accordance to the company’s procedures
• To undertake reviews of audit packs and certification decisions of medical device conformity assessment packs in close collaboration with Operations in accordance to the company’s procedures, KPI’s and targets.
• To plan and conduct professional medical device QMS audits in accordance with the company’s procedures and approved technical areas to enable delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards;
• To plan and undertake technical documentation assessments of medical devices in accordance with the company’s procedures and approved technical areas to enable delivery of assessment and certification services that meet customer requirements and appropriate accreditation standards;
• To support the achievement of medical devices operational and financial targets;

Profile:

• Must be able to demonstrate and excellent working knowledge of medical device management and regulatory systems, standards and compliance/auditing techniques (Essential)
• Minimum of 5 years working experience for a Medical Device Notified Body (Essential)
• Minimum of 5 years working experience as Medical Devices Lead Auditor and Product Assessor status (Essential)
• Effective interpersonal skills; able to develop good working relationships with people at all levels (Essential)
• Willingness to learn and adapt to change - committed to continuous personal and professional development (Essential)
• Experience of working under own initiative and in planning and prioritising workloads (Essential)
• Experience of reviewing audit packs (desirable)
• Registered IRCA lead auditor, or equivalent registration under other recognised body (Desirable)
• Tertiary technical qualification (university degree or equivalent) (essential)

CE MARKING / CERTIFICATION / NOTIFIED BODY / REGULATORY AFFAIRS / AUDITING / AUDITOR / QA / QUALITY ASSURANCE / CLINICAL / SCIENTIFIC / SENIOR / TECHNICAL / IVD / CE / 13485 / HEAD OF / NB / NBOG / HEALTHCARE / MEDICAL / STATISTICIAN / BIOSTATISTICIAN / BIOMEDICAL / BIOENGINEERING / MANAGER / USA / UK / UNITED KINGDOM / LONDON / MILTON KEYNES / BEDFORDSHIRE / MIDLANDS / OXFORD / OXFORDSHIRE / CAMBRIDGESHIRE / SOUTH WEST / SWINDON / WILTSHIRE / GLOUCESTER / GLOUCESTERSHIRE / BRISTOL / SOMERSET / HAMPSHIRE / SURREY / MIDDLESEX / BERKSHIRE / SE LONDON / KENT / SUSSEX / NORTHAMPTON / NORTHAMPTONSHIRE / EAST ANGLIA / SUFFOLK / NORFOLK / ESSEX / CAMBRISGESHIRE / CAMBRIDGE / PETERBOROUGH / BEDFORD / HERTS/ HERTFORDSHIRE / INTERTEK / UL / BUCKS / BUCKINGHAMSHIRE / HEREFORSHRIE / STAFFORD / STAFFORDSHIRE / CHESHIRE / NOTTINGHAM / NOTTINGHMASHIRE / MANCHESTER / M62 / M1 / M25 / M20 / M5 / M6 / LANCASTER / LANCASHIRE / LEEDS / YORK / YORKSHIRE / ENGLAND / WALES / MILTON KEYNES / BEDFORD / BEDFORDSHIRE / NORTHAMPTON / HAMPSHIRE / BASINGSTOKE / SOUTHAMPTON / BRIGHTON / SOUTH EAST / CAMBRIDGE / CAMBRIDGESHIRE / NORFOLK / NORWICH / SUFFOLK / IPSWICH / HAVERHILL / ROMFORD / MIDDLESEX / SLOUGH / WEST SUSSEX / SURREY / MAIDSTONE / DARTFORD / TONBRIDGE / HYTHE / ASHFORD / BIRMINGHAM / LEICESTER / LEICESTERSHIRE / NOTTINGHAM / NEWCASTLE / YORK / GRIMSBY / LINCOLN / LINCOLNSHIRE / WORCESTER / WORCESTERSHIRE / WARWICK / WARWICKSHIRE / HEREFORD / HEREFORDSHIRE / SOMERSET / BATH . 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, 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 / ZURICH / GENEVA / 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

Required skills

  • Certification
  • Management
  • Medical Devices
  • Technical Manager
  • Notified Body

Reference: 32296385

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