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Medical Doctor, Anaesthesiologist to Intertek

The Notified Body within Intertek is accredited to certify companies according to the EU Medical Device Directive (MDD) and EU Medical Device Regulation (MDR). Reviewing documentation, assessing products, performing quality management system audits and unannounced audits are part of the certification and the Notified Body's department.
Upprättad
Ansökningsfrist
Löpande urval
Förväntad start.
Så snart som möjligt
Anställningsförhållanden
Projekt
Antal timmar
Deltid (mindre än 21 timmar/vecka)
Anställning
Fast
Region
Sverige > Stockholms stad > Stockholms län

This role has accountability to support the operation of the business by providing clinical oversight of the client’s medical devices clinical evaluation reports and clinical post-market surveillance to ensure compliance with the conformity assessment per set requirements.

As an In-House Clinician at Intertek Medical Notified Body your responsibility would be to provide internal advice on clinical matters for medical devices within your area of expertise and conduct In-House Clinician Reviews in accordance with the documented procedures and forms. This include, but are not limited to the following additional responsibilities:

  • Be able to make an assessment of the manufacturer’s clinical evaluation and a clinical judgement of the opinion provided by any external expert and make a recommendation to the notified body’s decision maker
  • Liaising with technical documentation assessors with respect to clinical evaluation assessments
  • As a member of the Clinical Team engaging in activities such as, but not limited to, Clinical Team meetings, Post Market clinical follow up actions, vigilance, etc.
  • Maintaining ethical and professional clinical codes of conduct
  • Identify when further specialist input is required for the assessment of the clinical evaluation.
  • Be able to review and scientifically challenge the clinical data contained within the clinical evaluation and any associated clinical investigation, and appropriately guide external clinical experts in the assessment of the clinical evaluation presented by the manufacturer
     

Requirements

We are looking for an experienced Medical Doctor with knowledge within Anaesthesiology/ICU with knowledge of the following devices

  • Anaesthetic devices, devices for emergencies and intensive care
  • Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
  • Active non-implantable respiratory devices
  • Active non-implantable devices for monitoring of vital physiological parameters
     

We expect you to have at least two (2) years working experience as MD.  It is also a requirement that you maintain appropriate registration requirements with a licence to practice. If you have had experience in clinical investigation in the EU involving medical devices that is an advantage.

Our European head office is located in Kista, Stockholm Sweden but this position holder can be home based anywhere in Sweden or UK.

This is a part time position of 20-30% project based.

About Intertek 
Intertek is the trusted service provider to many of the world’s leading brands, companies and governments, and has earned a reputation for accuracy, reliability, integrity, and technical competence. 
Our Assurance, Testing, Inspection and Certification services take us into nearly every field, from textiles, toys and electronics, to building, heating, pharmaceuticals, petroleum, food, cargo scanning and medical devices.
In a world where a company’s success depends on its reputation for quality, safety, and socially responsible products and processes, Intertek employees make a difference. 
Join the team at Intertek and work with some of the best, brightest, and most inspiring people in the assurance, testing, inspection, and certification industry. 

Skicka din ansökan

In this recruitment Intertek is collaborating with PharmaRelations. If you have any questions please contact Helena Marteus 070-1652259 helen.marteus@pharmarelations.se or Åsa Norgren 070-165 22 63 asa.norgren@pharmarelations.se

The application process is ongoing so please apply as soon as possible through PharmaRelations website www.pharmarelations.se



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