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.
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.
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.
For more information or to apply for this Medical Device Consultant role, please contact Naynesh Mistry on 0114 283 9956 or email firstname.lastname@example.org. Please quote reference SH24454 in all correspondence.