DURAL IMPLANTS TECHNICAL PRODUCT EXPERT - EMEA

Posted 3 December by Bosch Global Associates Ltd

DURAL IMPLANT TECHNICAL PRODUCT EXPERT/SPECIALIST.

Industry: Implants / Soft Tissue/ Tissue Engineering / Dural

Location: ANYWHERE Home/Office Based.

Salary: >65k GBP

Bonus: >15%.

Training: Yes (Full).

Type: Permanent.

Scope:

The jobholder will be a member of the Global General Devices Team reporting to the Certification Lead and work as a colleague with other members of the Medical Devices Business Stream.

Purpose:

  • Provide specialist regulatory, operational and strategic support to medical device scheme managers, products specialists and the business in the delivery of CE medical device marking schemes
  • Deliver technical reviews and certification scheme management in support of CE marking.
  • Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise relating to Dural Implants.
  • Provide Medical Device expertise leadership and mentoring in areas of competence to medical devices personnel.
  • Provide "Technical Sales/Networking" support to the commercial team and promote the business.
  • Provide in-house and external training for wound care devices.

Key Responsibilities:

  • Deliver Medical Device CE Marking technical reviews, scheme management and ISO 13485 QMS assessment services
  • Work with technical team leaders as required to provide QMS assessment within area of expertise
  • Provide advice and support to product specialists and scheme managers on certifications in area of expertise that may have a regulatory challenge
  • Participate in client meetings to facilitate CE marking processes.

Knowledge / Skills:

  • BSc, MSC or PhD degree in a discipline relevant to medical device manufacture and use, or equivalent qualification
  • Thorough knowledge of the design and development of medical devices in area of experience, including the principles of design control, risk management and performance or clinical evaluation
  • Experience ideally will include one or more of the following: breast implants, dural implants, (duraplasty, duraform, graft implant, collagen, dura implant, dental implants, gelfilm, cranioplastic, etc. )
  • Familiarity with combination products incorporating medicated and antimicrobial agents would be beneficial
  • Thorough knowledge of Medical Device regulation

REVIEWER / IMPLANTABLES / AIMD / SOFT TISSUE / SURGICAL / DURAL / GELFILM / NEUROLOGICAL / BRAIN / DENTAL / ADHESIVE / IMPLANTABLE / NEUROPROSTHETICS/ CLINICAL / MEDICINE / QA / QMS / QUALITY MANAGEMENT / QUALITY ASSURANCE / ISO13485 / FDA / 21 CFR / 2001/82/EC / MEDICINAL / DRUG DELIVERY / DRUG COMBINATION / BIOCOMPATIBILITY / RISK ASSESSMENT / TECHNICAL REVIEWER / SCHEME MANAGER / TECHNICAL MANAGER / VALIDATION / VERIFICATION / AUDITING / AUDITORS / REGULATORY AFFAIRS / R&D / MEDICAL DEVICES / RESEARCH / DEVELOPMENT / MANUFACTURING / ENGINEERING / VASCULAR / CERTIFICATION / QMS / RESEARCH / PRODUCT DEVELOPMENT / NPD / NPI / MANUFACTURING / HEALTHCARE / PROCESS ENGINEER / PRODUCTION / NPD / PHARMA / PHARMACEUTICALS / R&D MANAGER / RESEARCH MANAGER / DEVELOPMENT MANAGER / HEAD OF R&D / RESEARCH / DEVELOPMENT / MEDICAL DEVICES / STERILES / BOSTON SCIENTIFIC / ORTHOPEADIC / DENTAL / R&D / OPHTHALMIC / SOFT TISSUE / VASCULAR / IMPLANTS / IMPLANTABLES / WOUND CARE / WOUNDCARE / CARDIOVASCULAR / VASCULAR / MEDICAL DEVICES / ELECTRO SURGICAL / SURGICAL DEVICES / GERMANY / EUROPE / BELGIUM / SWITZERLAND / RADITATION/ BENELUX, BELGIUM, SWITZERLAND, FRANCE, GERMAN / ENGLAND / US / USA / AMERICA / ABBOTT / SANOFI / FRESENIUS / KABI / GAMBRO / BAXTER / BARD / MEDTRONIC / KARL STORZ / TUV / SGS / KEMA / DEKRA / INTERTEK / UL / UNIVERSAL LABORATORIES / BBRAUN / SORIN / GE HEALTHCARE / SMITHS MEDICAL / VARIAN / SUPERSONIC / SWEDEN / AUSTRIA / BELGIUM / FRANCE / PARISOLYMPUS / BESPAK / DIAGNOSTICS / COOPERVISION / SAUFLON / BAXTER / BBRAUN / NIKKISO / TERUMO / OLYMPUS / BESPAK / DIAGNOSTICS / NIKKISO / TERUMO / DEPUY / SYNTHES / CARL ZEISS / MEDITEC / TELEFELX / JOHNSON / DAVOL / XELTIS / STRAUMANN / NANONERVE / SPLINTEK / ZIMMER BIOMED / NEUWAVE / INTEGRA / COVIDIEN / CR BARD / ETHICON / NEOMEND / SANOFI / FRESENIUS / KABI / GAMBRO / BAXTER / DRUG DELIVERY / CAREFUSION / SIEMENS / PHILIPS / SGS / LRQA / LGE / BUREAU VERITAS / BBRAUN / SORIN / GE HEALTHCARE / SMITHS MEDICAL / BIOMET / LOMBARD / MEDICAL / BIOMEDICAL / DEPUY SYNTHES / PFIZER / GSK / GLAXO / WYETH / MEDTRONIC / TISSUE REGENIX / SCIENTIFIC / SCIENCE / CLINICAL / PROJECT MANAGEMENT / PROJECT MANAGER / CRO /SSL/MOLYNCKE/SURGICAL / SCIENTIFIC / FORMULATION / CE MARKING / CERTIFICATION / USA / UK / UNITED KINGDOM /TISSUE SCIENCE/ /MEDINA/BEIERSDORF/ITALIAN/PFIZER/SYSTAGENIX/MOLNLYCKE/COVIDIEN/BAXTER/J&J/JOHNSON JOHNSON/SIGVARIS/COLOPLAST/GEM/BSN/B BRAUN / HOLLISTER / MEDLINE /CE MARKING / CERTIFICATION / 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 / 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

breast implants, dural implants, meshes, fillers, sutures, surgical sealants, anchors, scaffolds, cartilage, ligament repair.

Required skills

  • Clinical
  • Global R&D
  • Medical Devices
  • Product Development
  • Soft Tissue

Application question

Do you have at least 5 years R&D or product development expertise in medical devices?

Reference: 30567434

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