Job Description
+ Assist consulting team and clients with the preparation and submission of medical device registration/licensing applications to a single or specific number of regulatory markets.
+ Prepare renewals or amendments to the above, and act as support to a project team lead (project manager or consultant); this may include direct client interaction which should be well documented.
+ Develop and leverage knowledge of requirements and expectations for medical device submissions, understand the registration process, including whether tasks should be completed in parallel or sequentially and clearly delineate each process/phase to clients.
+ Assist with client documentation review, gap analysis, provide input regarding the acceptability of existing data, and explain how to satisfy the submission requirements.
+ Assist with or redirect internal or external inquiries related to quoting project hours and scope, including potential grouping or classification...
+ Prepare renewals or amendments to the above, and act as support to a project team lead (project manager or consultant); this may include direct client interaction which should be well documented.
+ Develop and leverage knowledge of requirements and expectations for medical device submissions, understand the registration process, including whether tasks should be completed in parallel or sequentially and clearly delineate each process/phase to clients.
+ Assist with client documentation review, gap analysis, provide input regarding the acceptability of existing data, and explain how to satisfy the submission requirements.
+ Assist with or redirect internal or external inquiries related to quoting project hours and scope, including potential grouping or classification...
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