WillHire
Regulatory Affairs Specialist III
WillHire, Pleasanton, California, United States, 94566
Summary:Manage activities associated with regulatory approval of in vitro diagnostic medical devices. Responsible for activities which lead to and maintain domestic and international regulatory approval to market devices. Responsible for assessment of device changes for regulatory implications.
Responsibilities:
Provides support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.Responsible for drafting submissions and maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations.Manages submission activities for a variety of device regulatory approvals including the IVDR/CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings.May review, interpret, and report Regulatory leadership on product specific regulatory issues that may have material impact on the business units, the corporation, or the customer.Interfaces with regulatory authorities on regulatory and technical matters, as appropriate.Provides regulatory support on project teams.May provide consultative and training support to the business unit and core regulatory personnel related to premarket submissions, product labeling, and complex submissions issues.May perform other duties as required or assigned.
Formal Training/Education:
Bachelor's Degree B.S./B.A. in a science, engineering, or related technical field; advanced degree preferred.Regulatory Affairs Certification preferred.
Experience:
5 years of experience in regulatory affairs in IVD or medical devices. IVD device experience is preferred.Experience with Microsoft based applications and general knowledge of PC functions is necessary.Experience with regulatory submissions including IVDR CE submission, IDE, 510(k), and PMA submissions is preferred.CDx specific experience in diagnostics or biomarker development with emphasis on oncology a plus.
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Responsibilities:
Provides support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance and for changes requiring regulatory agency approval, as pertains to US and international regulatory requirements.Responsible for drafting submissions and maintenance of product technical files and for ongoing activities related to compliance with Global Regulatory directives and regulations.Manages submission activities for a variety of device regulatory approvals including the IVDR/CE mark, US premarket approvals (PMAs), US premarket notifications (510(k)s), post-approval reports, annual reports, export certificates, and establishment registrations and device listings.May review, interpret, and report Regulatory leadership on product specific regulatory issues that may have material impact on the business units, the corporation, or the customer.Interfaces with regulatory authorities on regulatory and technical matters, as appropriate.Provides regulatory support on project teams.May provide consultative and training support to the business unit and core regulatory personnel related to premarket submissions, product labeling, and complex submissions issues.May perform other duties as required or assigned.
Formal Training/Education:
Bachelor's Degree B.S./B.A. in a science, engineering, or related technical field; advanced degree preferred.Regulatory Affairs Certification preferred.
Experience:
5 years of experience in regulatory affairs in IVD or medical devices. IVD device experience is preferred.Experience with Microsoft based applications and general knowledge of PC functions is necessary.Experience with regulatory submissions including IVDR CE submission, IDE, 510(k), and PMA submissions is preferred.CDx specific experience in diagnostics or biomarker development with emphasis on oncology a plus.
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