Medical Device Specialist

Cure Talent are delighted to be partnered with a growing medical device certification organisation that is expanding its technical and clinical assessment capability across a number of new medical device categories.

We are looking to speak with experienced Medical Device professionals who could support the organisation on an ad hoc contractor basis across auditing, technical review, product review and clinical assessment.

These are specialist positions rather than developmental opportunities. Candidates will need to demonstrate significant, directly relevant experience within at least one of the following areas:

Specialist Areas

• MDA 0102 | Active Implantable Drug Delivery Devices
  Implantable pumps and other active implantable devices used to deliver drugs or substances.
• MDA 0201 | Diagnostic Imaging / Ionising Radiation
  X-ray, CT and other diagnostic imaging technologies utilising ionising radiation.
• MDA 0317 | Cleaning, Disinfection & Sterilisation Devices
  Sterilisers, autoclaves, washer-disinfectors and related decontamination technologies.
• MDN 1102 | Osteo & Orthopaedic Implants
  Orthopaedic implants, trauma, spinal, joint reconstruction and associated technologies.
• MDN 1206 | Ophthalmologic Devices
  Ophthalmic and ophthalmologic medical devices, including relevant product-review experience.
• MDN 1210 | Contraception & STI Prevention Devices
  Condoms, barrier contraception and associated sexual and reproductive health devices.
• Endocrinology & Diabetes
  Clinical expertise within endocrinology and diabetes. A medical degree is required for this area.

Depending on your background, responsibilities may include:

• Medical Device auditing and conformity assessment.
• Technical documentation and technical file review.
• Product review and technical assessment.
• Clinical expert assessment.
• Reviewing evidence against applicable MDR requirements, standards and guidance.
• Producing clear, technically robust reports and documented conclusions.
• Working directly with manufacturers and other technical or clinical specialists.

The Ideal Candidate Will Have

• Significant Medical Device experience within at least one of the specialist areas above.
• Direct technical, clinical, Quality, Regulatory or product experience relevant to that category.
• A relevant scientific, engineering, medical or clinical qualification.
• The ability to clearly evidence their competence through previous products, projects, qualifications and professional experience.
• Strong knowledge of the regulatory and technical requirements relevant to their specialist area.
• The ability to work independently and make clear, evidence-based assessments.

Previous Notified Body, Approved Body, auditing or conformity-assessment experience would be advantageous, but strong manufacturer-side industry experience will also be considered where it directly aligns with the required device category.

Contract Arrangement

These are ad hoc contractor positions rather than full-time assignments.

Successful specialists will initially join the organisation's contractor panel, with assignments allocated as the relevant areas develop. There is no guaranteed volume of work at the outset, making the opportunity particularly suitable for experienced consultants, freelancers and specialists looking to build an additional long-term client relationship alongside existing work.

#J-18808-Ljbffr

Full job description from WhatJobs. Apply for this role →