In House Internal Clinician
Would you like to be an integral part of ensuring patient safety across the European Union?
We currently have an exciting opportunity in our Medical Device Notified Body to join our existing team of Internal Clinicians. Internal Clinicians for UK Notified Bodies must be in current clinical practise, and therefore this role is offered part-time, for 2.5 days per week. This is a home-based role within the UK.
Within this role you will:
- Contribute essential clinical expertise within your medical specialism to medical device conformity assessments. This includes input into evaluations of:
- Equivalence rationales and risk assessments
- Appropriateness of clinical claims, indications and contraindications for use, and user information and warnings
- Adequacy of endpoints, follow-up and clinical evaluation data
- adequacy of post market clinical follow up provision and follow up
- Mentor BSI technical staff and external clinical experts, to ensure consistency and rigour in clinical data reviews
- Help to develop internal “best practise” guides for clinical evaluation and data requirements within your specialism
- Act as clinical support to the commercial team when required
- Provide internal and external training in areas of expertise
Key responsibilities of this role are to:
- Develop and maintain an understanding of the regulation of medical devices in the EU, and the position on clinical reviews within it
- Be part of a team undertaking clinical oversight of all clinical evaluation assessments within the Notified Body
- Liaise with subcontracted clinical expertise, and manufacturers’ clinical directors if necessary, to ensure any clinical concerns are adequately addressed
- Develop clinical best practise guides and ensure consistency of clinical review for all clinical data reviews being undertaken by BSI
- Provide clinical expertise to clinical evaluations of medical devices in area of clinical competence
- Deliver all services within required timescales and to a high quality
- Maintain client satisfaction whilst continuing to meet BSI’s ethical expectations
- Maintain competence in area of clinical expertise by practising as a clinician in line with MHRA expectation
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 device; 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 is exciting opportunities for further growth of the Medical Devices team.
To be successful in this role you'll be a secondary care experienced clinician who has worked with a variety of medical devices, complementary to our existing in-house expertise. This might be in a high risk area such as;
- Orthopaedic surgery (ideally spine, hip or knee) or, ITU / ICU; active implantable devices
You will also ideally:
- Have experience with analysing clinical data and working with biostatisticians
- Have experience in clinical trials either as a Principal Investigator or a team member
To apply please click the apply button.
Closing date: 5 September 2018.