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Regulatory Affairs Specialist – Medical Devices

Pharmalink Consulting specialise in providing Regulatory Affairs expertise to the worlds leading Healthcare Organisations, with offices in the UK, USA and India. With our continued success and unprecedented growth, we are now looking for a Medical Devices Specialist to join our growing team on a permanent basis.

You will have extensive Medical Devices experience, including 510(K), CE Marking, Classes I, II (and some III) Medical Devices experience along with full working knowledge of the EU Medical Devices Directive with ISO 13485 & ISO 60601. This role will also involve you being our ‘go to’ person in all matters relating to Medical Devices, including assisting the Commercial Team with writing proposals and visiting clients to discuss potential projects.

Business acumen and the ability to communicate at all levels is essential for this role, alongside your technical expertise.

This role offers a varied and diverse permanent Consulting opportunity to work with the best Regulatory Professionals in the business.

Send your CV today to lquinlan@pharmalinkconsulting.com for more information and an informal discussion.

Location
Maidenhead UK

Client
Maidenhead UK

Job Type
Permanent



Interested? Apply Now.


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  10. Relevant Skills
  11. Prescription Drugs*
  13. Biotech*
  15. Devices*
  17. OTC*
  19. Generics*
  21. CMC eg review/preparation of QOS*
  23. Manufacturing compliance*
  25. Audit work eg CMP, GLP, GCP*
  27. Clinical eg review of protocols, IB, CSRs, Module 2 & 5 documents*
  29. Postmarketing maintenance eg variations/sNDA, postmarketing commitments/safety reporting*
  31. Regulatory operations eg CTD/eCTD/dossier preparation*
  33. Original NDA/MAA filings*
  35. Labeling*
  37. Advertising and promotion*
  39. Regulatory strategy eg RA meetings, filing strategy*
 


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