The following job is no longer available:
SOFT TISSUE TECHNICAL PRODUCT EXPERT - MEDICAL DEVICES

SOFT TISSUE TECHNICAL PRODUCT EXPERT - MEDICAL DEVICES

Posted 13 August by Bosch Global Associates Ltd
Easy Apply Ended

SOFT TISSUE IMPLANT PRODUCT EXPERT - MEDICAL DEVICES - USA

Industry: Implants / Soft Tissue/ Tissue Engineering / Wound care / Woundcare.

Location: ANYWHERE - Home OR Home/Office Based, USA.

Salary: 100-125k US.

Training: Yes (Full).

Type: Permanent.

Scope:

The jobholder will be a member of the 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 woundcare.
  • 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, meshes, fillers, sutures, surgical sealants, anchors, scaffolds, or cartilage and ligament repair.
  • Familiarity with combination products incorporating medicated and antimicrobial agents would be beneficial
  • Thorough knowledge of Medical Device regulation

REVIEWER / IMPLANTABLES / AIMD / SOFT TISSUE / SURGICAL / MECHANICAL / 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 / CLASS 1 / CLASS 2 / CLASS 3 / CLASS 3A / CLASS 3B / CLASS I / CLASS II / CLASS III / 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 / 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 / engineer, development engineer, product development, design, ABBOTT / 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 / VARIAN / SUPERSONIC / 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/ITALY/ROME/MILAN/FLORENCE/MEDINA/BEIERSDORF/ITALIAN/PFIZER/SYSTAGENIX/MOLNLYCKE/COVIDIEN/BAXTER/J&J/JOHNSON JOHNSON/SIGVARIS/COLOPLAST/GEM/BSN/B BRAUN / HOLLISTER / MEDLINE / Florida, Texas, New York, el paso, Texas, Alabama, dallas, Arkansas, Missouri, Tennessee, Wyoming, Colorado, San Diego, New Jersey, San Diego, Louisiana, Houston, San jose, Milwaukee, Detroit, oregan, atlanta, maryland, vermont, hampshire, massachusetts, philadelphia, Denver / breast implants, dural implants, meshes, fillers, sutures, surgical sealants, anchors, scaffolds, cartilage, ligament repair,California, North East, Minneapolis, Utah, Florida, Texas, New York, Carolina, Virginia, Pennsylvania, Ohio, Carolina, Toronto, San Francisco, Los Angeles, Utah, Nevada, Idaho, Montana, Nebraska, Dakota, Las Vegas, Oregan, Washington, Chicago, Iowa, Indiana, Michigan, New York, Toronto, Pennsylvania, Kentucky, New Jersey, Connecticut, Missisippi, Houstan, Texas, Alabama, Louisianan, dallas, Arkansas, Missouri, Tennessee, Wyoming, Colorado, Santa monica, Long Beach, Newport Beach, Irvine, Anaheim, simi valley, Ontario, Thousand Oaks, San Clemente, Oxnard, Santa Barbara, Palmdale, San Bernadino, Hesperia, Apple Valley, Orange County, Pasadena, Compton, Manhattan Beach, Santa Ana, Santa Rosa, San Jose, Sacramento, Daly City, San Mateo, Berkeley, Walnut Creek, Fairfield, Santa Cruz, Watsonville, Pescadero, Pleasanton, Palo Alta, Milpitas, Redwood City, San Bruno, Fremont, Alameda, El Granada, San Francisco, Emeryville, Colma, Millbrae, Belmont, Sausalito, America, USA, United states of America, west coast, san diego

Required skills

  • Medical Devices
  • Medical Technology
  • Product Development
  • Project Management
  • R&D

Reference: 30037699

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