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