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REGULATORY AFFAIRS SPECIALIST

 

Job Reference Number

14570560

Client ID:

RI/LTS RAS SW

Posted On:

Feb 17 2012

Location:

MUNSTER

Job Type:

Contract

Salary:

COMPETITIVE

Lotus Technical Services , a division of the LotusWorks organisation, is a leading solutions provider offering a complete range of automation and technical services. Lotus Technical Services specialises in Calibration, Start-up, Commissioning, Operation & Maintenance of Mechanical and Electrical Systems, CE Marking & Asset Management Consulting. We work closely with leading companies in the Advanced Technologies, Bio-Pharmaceutical, Medical Device, Semiconductor, Food & Beverage and Energy industries in Ireland and abroad.

The role of Regulatory Affairs Specialist will ensure compliance of regulatory procedures related to a product development project. Working closely with QA the role will involve ensuring quality standards are compliant to the regulations (FDA, ISO).

Skills & Qualifications

    Degree Qualified with at least 3 years Regulatory Affairs experience within the Medical Devices/Pharmaceutical Industry Excellent IT skills Quality Assurance and Validation experience Good report writing skills. Risk management experience Ability to work on own initiative
Lotus Technical Services is an Equal Opportunities Employer