Great that you're thinking about a career with BSI!

Job Title: In-House Clinician

Reports to: Clinical Oversight

Location: Homebased - UK, Netherlands or Spain, France, Italy or Germany

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, ideally for 2.5 days per week. This is a home based role in either the UK or Netherlands, or alternatively Spain, France, Germany or Italy.

Specifically for this role, we are looking for either an Orthopaedic Consultant who has specialised in shoulder and upper limb surgery . Your current clinical practice must involve a minimum of 50% upper limb surgery. A minimum of five years consultant experience would be preferred.

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 assessmentsappropriateness of clinical claims, indications and contraindications for use, and user information and warningsadequacy of endpoints, follow-up and clinical evaluation dataadequacy of post market clinical follow up provision and follow upMentor BSI technical staff and external clinical experts, to ensure consistency and rigour in clinical data reviewsHelp to develop internal “best practise” guides for clinical evaluation and data requirements within your specialismProvide 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 itBe part of a team undertaking clinical oversight of all clinical evaluation assessments within the Notified BodyLiaise with subcontracted clinical expertise, and manufacturers’ clinical directors if necessary, to ensure any clinical concerns are adequately addressedDevelop clinical best practise guides and ensure consistency of clinical review for all clinical data reviews being undertaken by BSIProvide clinical expertise to clinical evaluations of medical devices in area of clinical competenceDeliver all services within required timescales and to a high qualityMaintain client satisfaction whilst continuing to meet BSI’s ethical expectationsMaintain competence in area of clinical expertise by practising as a clinician in line with MHRA expectation

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 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.   

What we offer;

This role offers a competitive and reasonable package, and a wide range of flexible benefits that you can tailor to suit your life-style.

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Our Excellence Behaviours: Client-centric, Agile, Collaborative. These three behaviours represent how we do things at BSI. They help us ensure that BSI is a great place to work and a highly successful business.

BSI is conducting face-to-face interviews where appropriate and possible. If you are invited to a face-to-face interview but feel more comfortable with conducting the interview virtually, please speak to a member of our recruitment team.