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SOFT TISSUE TECHNICAL PRODUCT EXPERT – MEDICAL DEVICES

SOFT TISSUE IMPLANT PRODUCT EXPERT - Medical DEVICES - USA

Business: Implants / Gentle Tissue/ Tissue Engineering / Wound care / Woundcare.

Location: ANYWHERE - House OR House/Workplace Based mostly, USA.

Wage: one hundred-125k US.

Coaching: Sure (Full).

Sort: Everlasting.

Scope:

The jobholder might be a member of the Basic Units Workforce reporting to the Certification Lead and work as a colleague with different members of the Medical Units Enterprise Stream.

Objective:

  • Present specialist regulatory, operational and strategic help to medical system scheme managers, merchandise specialists and the enterprise within the supply of CE medical system marking schemes
  • Ship technical evaluations and certification scheme administration in help of CE marking.
  • Construct, management and handle a portfolio of Medical System CE marking schemes targeted round your space of experience referring to woundcare.
  • Present Medical System experience management and mentoring in areas of competence to medical units personnel.
  • Present "Technical Gross sales/Networking" help to the business staff and promote the enterprise.
  • Present in-home and exterior coaching for wound care units.

Key Obligations:

  • Ship Medical System CE Marking technical evaluations, scheme administration and ISO 13485 QMS evaluation providers
  • Work with technical workforce leaders as required to offer QMS evaluation inside space of experience
  • Present recommendation and help to product specialists and scheme managers on certifications in space of experience which will have a regulatory problem
  • Take part in shopper conferences to facilitate CE marking processes.

Information / Expertise:

  • BSc, MSC or PhD diploma in a self-discipline related to medical gadget manufacture and use, or equal qualification
  • Thorough information of the design and improvement of medical units in space of expertise, together with the rules of design management, danger administration and efficiency or medical analysis
  • Expertise ideally will embrace a number of of the next: breast implants, dural implants, meshes, fillers, sutures, surgical sealants, anchors, scaffolds, or cartilage and ligament restore.
  • Familiarity with mixture merchandise incorporating medicated and antimicrobial brokers can be useful
  • Thorough information of Medical Gadget regulation

Required expertise

  • Medical Units
  • Medical Know-how
  • Product Improvement
  • Venture Administration
  • R&D

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