Certification & Inspection Officer - IVD - Medical Devices

Location Galway
Job-type Permanent
Salary €67676 - €99638 per annum
Contact Grace Kilroy
Email email Grace
Reference J363839
Date Published about 1 month ago
Role: Certification & Inspection Officer Medical Devices
Location: Hybrid
Organisation: Semi-state
Salary: €67,676 - €99,638
Job Type: Full Time, Permanent, Monday Friday

TTM have an exciting opportunity with a national semi-state body recruiting a Certification and Inspection Officer.

The purpose of this role is to be responsible for performing conformity assessment activities under Regulation (EU) 2017/746 to CE mark IVD devices for use in the European Market.


Competitive Salary
Flexible working options
30 days annual leave

Key Requirements:

• Degree in relevant studies, e.g. Biomedical Science, Pharmacy, Medicine, Biotechnology, Engineering or other relevant sciences.
• Minimum of 4 years post graduate experience in the field of healthcare products or related activities, such as manufacturing, auditing or research is essential.
• Experience with:
o In vitro diagnostic medical device R&D, Manufacture or Design Assurance.
o Software as a medical device.
o Design, development, manufacture or servicing of IVD instrumentation.
o Verification and/or validation of IVD devices.
o Testing of clinical samples using IVD devices.
• A comprehensive understanding of IVDR Regulation (EU) 2017/746.
• Experience generating, compiling or reviewing performance data for IVDs.
• Strong understanding of conformity assessment activities for IVD medical devices, with particular emphasis on European requirements.

Click APPLY NOW to submit your application, alternatively you can send and updated copy of your CV to grace.kilroy@ttmhealthcare.com or call 01 513 4908 to discuss further.

TTM Healthcare Solutions is an Equal Opportunities Employer