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Regulatory Affairs Specialist

Waukegan, IL

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.

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