BSI Group

Medical Device Technical Specialist - Soft Tissue

Expiring today

Company
BSI Group
Location
Raleigh, NC, United States
Salary
Competitive
Posted
19 Sep 2019
Closes
19 Oct 2019
Ref
11697
Discipline
Healthcare
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
About the Role

We currently have a vacancy for a Soft Tissue Technical Specialist within the GeneralDevices team. This is an excellent opportunity to join a leading Notified Body, driving up the standard of safety and performance of Medical Devices for patients across Europe, and to be involved in the evaluation of cutting edge innovation and state of the art technologies.

This is a home-based role with up to 25% travel.

Purpose of Position
  • Provide specialist regulatory, operational and strategic support to medical device scheme managers, products specialists and BSI in the delivery of CE medical device marking schemes.
  • Deliver technical reviews and scheme management in support of the CE marking schemes.
  • Build, control and manage a portfolio of Medical Device CE marking schemes focused around your area of expertise relating to soft tissue 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 BSI.
  • Provide in-house and external training in areas of expertise.


Key Responsibilities:
  • Deliver Medical Device CE Marking technical reviews under MDD and MDR requirements, scheme management and ISO 13485 QMS assessment services.
  • 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.


About You

Job Requirements:
  • Bachelor's, Master's or PhD degree in a discipline relevant to medical device design, manufacture and use, or equivalent qualification.
  • At least five (5) years' experience in the design and development of medical devices in area of experience, including the principles of design control, risk management and performance and/or clinical evaluation
  • Experience with soft tissue implants and associated instrumentation/delivery systems in one or more of the following categories: breast implants, dermal fillers, lung implants, neural or dural implants, implants for bariatric surgery, hernia meshes and plugs, prolapse meshes, tissue reinforcement meshes, adhesion barriers, muscular implants, sutures, surgical sealants, fixation anchors, staple line reinforcements, and scaffolds for tissue regeneration or repair.
  • Knowledge of medical device regulations.
  • Awareness of certification business processes, the application of quality management standards, and audits.


About BSI

Do you believe the world deserves excellence?

BSI (British Standards Institution) has over 81,000 clients in 180 countries, and is an organization whose standards inspire excellence across the globe. BSI Medical Devices Notified Body provides rigorous CE and ISO 13485 certification to manufacturers globally. The team apply their knowledge to 3rd party conformity assessment of all types of medical devices; active devices, active implantable devices, in vitro diagnostic devices, orthopaedic and dental devices, vascular devices, wound care devices and many others. The team has doubled in size over the past eight years, demonstrating the company's desire to succeed and deliver world beating results. There are exciting opportunities for further growth of the Medical Devices team.

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