BSI Group

Clinical Evaluation Specialist - Vascular Medical Devices

Company
BSI Group
Location
Minneapolis, MN, United States
Salary
Competitive
Posted
19 Sep 2019
Closes
18 Oct 2019
Ref
11701
Discipline
Healthcare
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
About the Role

Due to continuing strategic growth within our Medical Devices business, we currently have vacancies for Clinical Evaluation Specialists on our Vascular Medical Device 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 home-based position is full-time, salaried, and involves up to 25% travel by car and plane for client meetings, trainings, and team meetings.

As a Clinical Evaluation Specialist you will be responsible for:
  • Carrying out detailed assessments of clinical data to ensure that Vascular Medical Devices meet the safety and performance requirements of the regulations
  • Compiling Clinical Evaluation Assessment Reports (CEAR's)
  • Managing the submission of CEAR's and supporting documentation to the EU Commission for clinical evaluation consultation, including addressing any feedback received
  • Working with Product Technical Specialists to determine the clinical impact of design changes and determining the level of clinical assessment required
  • Working with Internal Clinicians to ensure that the relevant External Clinical Experts and Clinical Statisticians are engaged in the clinical assessment process
  • Working with Internal Clinicians to ensure that the clinical requirements of the Medical Device Directive and Medical Device Regulations are being met
  • Working with Product Technical Specialists to ensure that the clinical aspects of Design Dossier and Technical File Reviews are completed on time
  • Providing specialist clinical support to medical device Scheme Managers, Product Technical Specialists and the business in the delivery of CE medical device marking schemes
  • Supporting Scheme Managers to ensure that manufacturers fulfil their obligations to carry out Post Market Clinical Follow-up studies
  • Working with Team Training Lead and Head of Clinical Compliance to prepare and deliver clinical training relevant to Vascular Medical Devices.
  • Participating in client meetings to facilitate CE marking processes
  • Working with Internal Clinicians to ensure appropriate qualification of External Clinical Experts whose services may be required in the BSI CE certification process
  • Planning and prioritising tasks logically according to regulatory priority, service level obligations and the needs of the business
  • Maintaining accurate records of activities, and competency records that meet regulatory and BSI procedural requirements
  • Keeping up to date with regulatory requirements and maintain a high level of awareness of changes in standards relating to the voluntary and mandatory certification in Europe and internationally

Medical Devices | Clinical | AIMD | Clinician #LI-MSFITZ

About You

The role requires you to have extensive experience with one or more of the following Vascular Devices:
  • stents and stent delivery systems
  • percutaneous heart valves
  • devices to treat abdominal aortic aneurysms ablation and electrophysiology catheters
  • neurovascular experience (embolic coils, neurovascular stents and related accessories)
  • Basic experience with other cardiovascular devices such as balloon catheters, PICC or CVC catheters, guide wires, introducers, closure devices and related accessories.

Required Skills/Education:
  • Thorough knowledge of the design, development and implementation of clinical trials
  • Working knowledge of ISO 14155 Clinical investigation for medical devices for human subjects - Good clinical practice, a working knowledge of MEDDEV 2.7/1, Rev 4, CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC.
  • Formal training as doctor of medicine (MD) or registered nurse (RN) is required.
  • Bachelor's degree in a discipline relevant to medical device manufacture and use (e.g. engineering, medical, nursing etc.), or equivalent qualification.
  • Five or more years' post graduate experience with Vascular Medical Devices involving Clinical study design or management or clinical data evaluation and systematic reviews of clinical literature or Vascular Device product training including providing product support and guidance to surgeons and physicians on implant techniques, product performance and product management.

Due to regulatory requirements, only candidates who are a qualified doctor of medicine (MD) or registered nurse (RN) will be considered.

About BSI

Do you believe the world deserves excellence?

BSI (British Standards Institution) has over 81,000 clients in 182 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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