Medical Device Assessor Job in Dnv Gl

Medical Device Assessor

Local Unit & Position Description

Key Accountabilities

• Conduct assessments (either desk-based or on client s sites) in accordance with established procedures, maintaining a high standard of service delivery that ensures effective customer relationships.
• Conduct Technical File reviews specific for products being authorized.
• Complete all chargeable work within the required budget and timeframes to ensure customer satisfaction and efficiency of the business.
• Complete specific projects in relation to medical device procedures, processes, systems and documentation as requested by the Medical Devices Operations Manager.
• If required, undertake reviews of packs and make certification decisions within target timescales and in line with DNV GL policies and accreditation/approval requirements.
• Project manage auditing teams, as appropriate, to maximize efficiencies, enhance client satisfaction and ensure compliance with standards.

Position Qualifications

• Assessors shall minimum have a Technical college degree in a relevant product or medical area, as described below or equivalent.
  Appropriate professional areas are listed below as examples.
  Non-active devices:
  a) biology or microbiology;
  b) biomechanical engineering;
  c) chemistry or biochemistry;
  d) dentistry
  e) human physiology;
  f) materials or biomaterials science;
  g) medical technology
  h) medicine, veterinary medicine;
  i) nursing
  j) pharmacy, pharmacology, toxicology;
  k) physics or biophysics;
  l) physiology;
  Min. 4 years work experience (full time) in the medical device related industry.
• 7+ years of work experience is desirable.At least 2 of the 4 years must be in the design, scientific aspects, manufacture, testing or use of the device to be assessed, and/or experience as an assessor in a notified body (full five technical documentation assessments). As part of this work experience, risk management experience should be covered.
• Practical experience in conducting pre-clinical testing or assessing preclinical data with medical devices in one or more of the following areas such as biological safety, physical, chemical and microbiological characterization, stability, shelf life, performance and safety
  A PhD in a relevant area for medical devices can substitute3 years of work experience provided that it includes 2 years experience in design, manufacture or testing .
• To be considered for this role, you ll professional experience in relevant field of healthcare products or related activities e.g.:
• Work in medical devices industry or closely related industries (e.g. pharmaceutical industry) such as research and development, manufacturing, quality management, regulatory affairs
• Work in health services, universities, foundations or other institutions carrying out inspections, audits, clinical evaluations, experimental and/or clinical research, including notified bodies
• Work in the application of device technology and its use in health care services and with patients
• Testing devices for compliance with the relevant national or international standards
• Conducting performance testing, evaluation studies or clinical trials of devices