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Regulatory Affairs Specialist

Company: Onward Technologies Inc
Location: Waukegan
Posted on: March 12, 2023

Job Description:

Title: Regulatory Affairs Specialist Location: Waukegan, IL Position Summary: A Regulatory Affairs Specialist who can handle Regulatory requirements related to EUMDR for a Software as a Medical Device (SaMD). Primary Duties: Perform gap analysis to understand the currents gaps in regulatory documentation with respect to EUMDR. Assess acceptability and completeness of documentation. Identify unmet needs and provide feedback. After assessing the gaps, compile , complete and organize documentation to ensure compliance to EU MDR requirements and support in submissions. Work closely with cross-functional teams. Interact with regulatory authorities and execute regulatory processes/submissions; provide feedback on submission review progress & questions; coordinate, write & review answers to competent authority questions; and report on issues. Must be an SME who can stay current with respect to regulatory changes & developments needed for submission requirements & processes. Participate in Design Control projects to advise responsible personnel on regulatory requirements & develop options with recommendations; develop software regulatory strategies; continually assess project output & impacts on regulatory the defined strategy / product launch date Understand & investigate regulatory history of similar products in order to assess regulatory implications for new products or changes to existing products Provide regulatory review and / or approval of product verification & validation documents, product labels, instructions for use, and advertising / promotional materials Assist in the development and review of procedures. Knowledge, Experience and Skills: B.S. in Software Engineering, Biomedical Engineering, or related field. 5+ years of experience in medical device industry, preferably in product development or engineering functions. Strong knowledge of standards - ISO 13485, ISO 82304, ISO 14971 Experience Software or SaMD preferred. Experience of having worked on EU MDR documentations.

Keywords: Onward Technologies Inc, Waukegan , Regulatory Affairs Specialist, Other , Waukegan, Illinois

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