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In this company you will support the set up of the HQ in the Midlands as the Legal Manufacturer and Authorised Representative for a range of medical device products.
You will work with the manaufacturing sites to obtain and refine the relevant information for the following activites:

1.  The preparation and submission of Design Dossiers for approval  by notified body.
2.  The generation of Technical Files to support the CE mark of associated products.
3.  Support the generation of required documentation to obtain CE Mark including Risk Analysis, Clinical Literature Review and completion of Essential Requirements checklists.
4.  The generation of procedures and systems to support a Quality System which deals with the legal responsibilities of the Manufacturer / Authorised Representative.

Skill and Competencies:

• Familiar with compilation and submission of Design Dossiers and Technical Files.
• Experience in the requirements of a Quality System to ISO13485:2003  and/ or FDA 21 CFR 820 in the Medical Device industry
• Experience in preparation of Submissions and Change Notices for Notified Bodies and the FDA.

-  Degree level Engineering or Scientific qualification

-  4 years Medical Device industry experience is a prerequisite.

 To apply please contact Catherine on 091- 563 868 or email cduggan@sigmar.ie