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Ref No.: 18-05369
Location: santa Ana, California
Position Type:Direct Placement
Start Date: 05/11/2018
As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Core job responsibilities for this function may include:
EUMDR Readiness:
. Work with RA core team lead to execute RA deliverables per project schedule, including Technical File compilation, Labeling review and other activities as assigned
. Be an extended team member, attend meetings and provide regulatory guidance as needed

. Assist in the creation of registration documentation (e.g. Technical Files; PMA supplements; 510(k) filings etc.,)

· Under supervision, create renewal documentation (e.g. Technical File updates; Annual Reports; country-specific documentation to support global RA team)
. Perform regulatory impact assessments for design/manufacturing changes

Job specific responsibilities may include (choose applicable areas and expand as appropriate);
· Medical writing
· Labeling
. Change assessment
· Compendial / standards
· Import / export
· Country specific regulatory support – specifically European Regulatory Requirements