Certification Manager - Medical Devices - Belgium

Posted 3 December by Bosch Global Associates Ltd
Easy Apply

Salary: Negotiable

Type: Permanent.

Location: Belgium - Anywhere


Job description:


• Ensure the integrity and compliance of all medical device certification processes and decisions
• Liaise with third party stakeholders (Regulatory Authorities) to ensure that certified organizations and devices comply with the standards and regulations and that patient safety is maintained
• Maintain required approvals and accreditation and manage the business risks to the company.
• Ensure the highest level of service through efficient service delivery / process optimisation
• Manage all critical conformity assessment processes (contract approval, assessment staff approval, assessment pack review and certification decision) provide to network
• Ensure that all assessment personnel follow current procedures and that all certification decisions are correctly based on documented assessment evidence.
• Ensure that appropriate impartiality and confidentiality are maintained by all medical device staff
• Develop and approve appropriate training of medical device staff and ensure that all conformity assessment staff are suitably qualified and trained
• To support the achievement of medical devices operational and financial targets;

Profile:

• Extensive knowledge and experience of the medical device certification business and regulations.
• A minimum of 5 years quality assurance and assessment experience including working for a Medical Device certification body
• University degree in a directly relevant technical subject further qualification desirable
• Clinical or direct device experience desirable
• Fluent in English , multiple language proficiency an advantage
• Team management experience
• Ability to work with management, technical auditing and administrative personnel at a corporate , international and affiliate level
• Ability to understand customer and market expectations and to be customer focused at a global and affiliate level.
• Excellent interpersonal and communication skills (highly developed presentation skills
• Negotiation and persuasion skills
• Change and Conflict Management skills
• Strong organizational skills and flexibility

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
  • Scientific Background
  • Certification Manager

Reference: 32294986

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