SOFT TISSUE IMPLANT PRODUCT EXPERT - Medical DEVICES - USA
Business: Implants / Delicate Tissue/ Tissue Engineering / Wound care / Woundcare.
Location: ANYWHERE - House OR Residence/Workplace Based mostly, USA.
Wage: one hundred-125k US.
Coaching: Sure (Full).
The jobholder can be a member of the Common Units Workforce reporting to the Certification Lead and work as a colleague with different members of the Medical Units Enterprise Stream.
- Present specialist regulatory, operational and strategic help to medical system scheme managers, merchandise specialists and the enterprise within the supply of CE medical gadget marking schemes
- Ship technical critiques 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 Gadget experience management and mentoring in areas of competence to medical units personnel.
- Present "Technical Gross sales/Networking" help to the business group and promote the enterprise.
- Present in-home and exterior coaching for wound care units.
- Ship Medical System CE Marking technical critiques, scheme administration and ISO 13485 QMS evaluation providers
- Work with technical staff 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
- Medical Units
- Medical Know-how
- Product Improvement
- Undertaking Administration