Medical Device Consultant – East Midlands

Naynesh Mistry at CK Science is looking to recruit a Medical Device Consultant to join a medical device organisation in the East Midlands on a permanent basis.

The job:

This purpose of this Medical Device Consultant role is:

  • Primarily providing Medical Devices Regulatory and Quality Management Systems consultancy
  • Devise and deliver training courses to customers
  • Provide a high quality service to all of the clients customers

This role is a home based role but travel within the UK and internationally is required. A driver’s licence is required for this role.

Responsibilities:

The main responsibilities of this Medical Device Consultant role will be to:

  • Provide consultation on Quality Management Systems
  • ISO 13485
  • 21 CFR 820
  • ISO 13485 CMDCAS and other Quality System standards as applicable to our customers
  • Write documentation including Technical Files, Design Dossiers, manuals, forms, templates, procedures etc as required for regulatory compliance of Customer’s products
  • Write documentation including manuals, forms, templates, procedures etc as required to implement Management Systems
  • Provide consultation on medical devices guidance documents (MEDDEVs, NBMEDs, TS, TIR)
  • Provide consultation on worldwide Medical Devices regulatory stand
  • Where suitably experienced, consult and work to other world market regulations (USA 510k, Canada SOR 98282 etc, Australia etc)
  • Attend sales meeting with customers if required
  • Support the Sales Team in pre-sales and marketing activities
  • Attend training courses if required

Qualifications and skills required:

The successful candidate for this Medical Device Consultant will have the following skills and qualifications:

  • Degree qualified in Life Sciences, or equivalent 
  • Relevant experience in Medical Device environment and Quality Management Systems
  • Thorough knowledge of CE marking
  • Thorough and practical working knowledge of ISO 13485
  • Practical working knowledge of Medical Devices Directive93/42/EEC and 2007/47/EC
  • Professional qualifications such as QP would be desirable.
  • Full UK driving licence and a car owner

A candidate that is a Lead Auditor and has knowledge and experience in worldwide regulations (i.e. USA 510k, Canada, Australia etc) would be an advantage.

Naynesh Mistry - Scientifc Recruitment Consultant at CK ScienceHow to apply:

Apply online:

For more information or to apply for this Medical Device Consultant  role, please contact Naynesh Mistry on 0114 283 9956 or email nmistry@ckscience.co.uk. Please quote reference SH24454 in all correspondence.

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