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Clinical Affairs Specialist Medical Devices Role, Washington


Our client is looking for a Clinical Affairs Specialist to join their rapidly growing organisation, who are very well placed in a number of consumable product areas including; Respiratory, Cardiothoracic, Chest Drainage, Fertility and Labour Ward devices.


This is an excellent opportunity to join a fantastic medical device brand, who is highly established in the UK market, expanding Internationally and really values its staff.
CANDIDATES REQUIRE CLINICAL AFFAIRS EXPERIENCE IN THE MEDICAL DEVICE MARKET TO BE CONSIDERED

The Clinical Affairs Specialist will ensure the collation and evaluation of pre- and post-market clinical data in support of the Rocket Medical devices.
updating and maintaining medical device technical file clinical evaluation reports (CERs) to MEDDEV 2.7/1 Rev. 4. In addition, the clinical affairs specialist will help in planning and coordination PMCF studies to MDR 2017/745. Assistance will also be provided in pre-market clinical investigation planning and execution.


Territory Details
Focussing on UK Market


Key Duties

  • Compiling, updating and maintaining medical device technical file clinical evaluation reports (CERs) to MEDDEV 2.7/1 Rev. 4
  • Assist with planning and coordination of post-market clinical follow-up (PMCF) studies to MDR 2017/745
  • Assist with pre-market clinical investigation planning, submissions and execution


Required competence

  • Educated to degree level in relevant discipline e.g. science or healthcare
  • Experience with clinical trials in medical devices industry
  • Working knowledge of MEDDEV 2.7/1 Rev. 4 including literature search techniques and data appraisal
  • Ability to learn and understand clinical procedures in order to evaluate clinical literature
  • Understanding and experience of working to the requirements of EN ISO 14155 'Clinical investigation of medical devices for human subjects - Good clinical practice' including a sound understanding of the creation of clinical study protocols
  • Knowledge of the Post-market surveillance requirements of Annex XIV Part B of MDR 2017/745
  • Experience of preparing submissions to ethics committees


Package and Benefits

  • Salary dependant on Experience - £35-£50 basic
  • Company Benefits
  • Time in Lieu / Flexi time
  • Work from Home Benefits


Key Skills, Qualifications and Client requirements

  • Undertake training and development as required
  • Self-Reliance, with the ability to work with the minimum of supervision utilising own initiative
  • The job entails interaction between departments within Rocket
  • Medical and external clinicians; it is essential that the jobholder has good interpersonal and communication skills
  • It is essential that the jobholder exhibits a high level of conscientiousness and accuracy in all tasks or duties
  • Good organisation skills and methodical approach to work
  • The jobholder must maintain and uphold the company values


What Happens Next?

If you are interested in finding out more about this role please click the ' Apply' button. On submission of the job application form, an email alert is sent to the specialist consultant handling this role to register your interest.
All dialogue with us is in the strictest of confidence, without any obligation and we will NOT send your details to the relevant business without your consent.
Alternatively, to find out more about this role or any other roles that maybe relevant, you can email us at [email protected] or call our Medical Devices team on 01423 813456

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