Regulatory Affairs Consultant II
Job Posting for Regulatory Affairs Consultant II at iTech Solutions
Experience: Minimum 2-5 years professional experience in the applicable role.
Education: Bachelor's degree or equivalent.
Supports product safety, compliance and regulatory function (SCR) performing the required activities that assure compliance with domestic and international regulatory agency requirements and standards. Prepares and submits registrations and CE mark documents. Is familiar with electrical safety and compliance test methodologies and with maintaining files and communicating changes in an evolving regulatory landscape. Familiar with quality system requirements. May handle or support requests for testing from country and/or regulatory agencies, prepare and submit product test requests and submissions to regulatory bodies. Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Develop and prepare safety and compliance test requests for US, Canada, EU and select worldwide locations. Review and approve engineering changes and labeling for regulatory compliance. Identify potential regulatory approval risks based on changes in regulations, standards country specific issues or other unique characteristics of the project
Education: Bachelor's degree or equivalent.
Supports product safety, compliance and regulatory function (SCR) performing the required activities that assure compliance with domestic and international regulatory agency requirements and standards. Prepares and submits registrations and CE mark documents. Is familiar with electrical safety and compliance test methodologies and with maintaining files and communicating changes in an evolving regulatory landscape. Familiar with quality system requirements. May handle or support requests for testing from country and/or regulatory agencies, prepare and submit product test requests and submissions to regulatory bodies. Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Develop and prepare safety and compliance test requests for US, Canada, EU and select worldwide locations. Review and approve engineering changes and labeling for regulatory compliance. Identify potential regulatory approval risks based on changes in regulations, standards country specific issues or other unique characteristics of the project
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