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REGULATORY AFFAIRS SPECIALIST

 

Job Reference Number

14564432

Client ID:

RI/EM87

Posted On:

Feb 1 2012

Location:

TIPPERARY

Job Type:

Contract

Salary:

NEG

Regulatory Affairs Specialist will be responsible for conducting audits of the quality system, as per defined audit schedule. Responsibilities: Creates audit checklists based on the assigned audit area, reflecting all applicable regulations, and pertinent quality system/procedural requirements, and obtains approval from Lead Auditor as appropriate. Evaluates the adequacy and compliance of systems, operations, and practices against regulations and company documentation. Formulates and documents nonconformities and obtains concurrence with responsible management. Tracks issues through to closure including reviewing the corrective action taken.

ExperienceBachelor’s degree plus 2+ years of related work experience with a basic understanding of specified functional area, or an equivalent combination of education and work experience. General knowledge and basic application of business concepts, procedures and practices.. Learns to use professional concepts and company policies and procedures to solve routine problems. Begins establishing and cultivating a network of internal resources to facilitate completion of tasks. Individual influence is typically exerted at the peer level. Completes daily work to meet established schedule with guidance from supervisor on prioritization of tasks. May exercise authority within preestablished limits and approval. Failure to achieve results can normally be overcome without serious effect on the business. Work is closely supervised. Follows specific, detailed instructions. Can provide direction and guidance to predominantly nonexempt personnel,evaluate performance of and assist in career development planning for subordinates. Can be responsible for a local functional or process activity