Description: Our client is currently seeking a Specialist, RAQA for a 12 month + contract.
Medical device experience is required.
As Specialist RAQA, you will support product recalls, including s scoping events, gathering information for records, executing events, and communication with stakeholders on events. support the commercial hold process, including supporting scope assessment, running distributions reports, executing and tracking commercial holds. Experience with ERPs, NC/CAPA systems, and basic understanding of regulation desired.
Co-ordinates and prepares document packages for regulatory submissions from all areas of the organization. Collects all materials required in submissions, license renewal, and annual registrations. Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies. Works on problems of complex scope where data analysis requires evaluation of specific factors. Utilizes independent judgment within broad parameters to determine an appropriate solution. May determine methods and procedures on new projects and may provide guidance to other lower-level staff. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision. Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree.
Contact: eronan@judge.com
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