Technical Pack Reviewer / Certification Decision Maker - Belgium

Posted 3 December by Bosch Global Associates Ltd
Easy Apply

Salary: Negotiable 60-80k Eur

Sector: Medical Devices / IVD / MDD / MDR

Type: Permanent.

Location: Belgium / Europe

Job description:

• To undertake technical reviews and certification decisions of audit packs within target timescales and in line with the company’s policies and accreditation/approval requirements
• Provide accurate and timely reporting as required by line management to assist the planning and management of operations
• Undertake personal professional development and ensure appropriate training records and personal logs are updated to maintain relevant auditor registrations and relevant industry knowledge
• To maintain a full knowledge and understanding of the company’s procedures and external approval criteria to allow efficient and effective technical reviews.
• To undertake other technical tasks as requested and support affiliates on technical projects
• Maintain medical device auditor status whilst not undertaking significant number of audits

Profile:

• Must be able to demonstrate and excellent working knowledge of medical device management and regulatory systems [MDD, IVDD, Accreditation], standards and compliance/auditing techniques (Essential)
• Effective interpersonal skills; able to develop good working relationships with people at all levels (Essential)
• Must be IT literate i.e. competent in the use of MS Office applications (Essential)
• Willingness to learn and adapt to change - committed to continuous personal and professional development (Essential)
• Minimum of 2 years working for a Medical Device Notified Body
• Minimum of 5 years medical device experience from auditing/work ( Essential)
• Minimum 3 year experience auditing against recognised standards (Essential)
• Approval as a Notified Body Product Assessor (not required to be active but must have had in past with NB)
• MDD, IVDD, CMDCAS auditor approval or part off (not required to be active but must have had in past with NB)
• 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)
• University Degree or equivalent

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
  • Medical Devices
  • Scientific Background
  • Technical Reviews
  • Notified Body

Reference: 32294637

Bank or payment details should not be provided when applying for a job. reed.co.uk is not responsible for any external website content. All applications should be made via the 'Apply now' button.

Report this job