Rangam · 1 day ago
RCI-ABO-43235 Quality Documentation Specialist / Regulatory Documentation Coordinator
Rangam is seeking a Quality Documentation Specialist / Regulatory Documentation Coordinator to review Electronic Instructions for Use (IFUs) submitted by Writers and the Localization Team. This role involves ensuring the accuracy of documentation and processing requests in systems for distribution, as well as collaborating with various teams to prepare records for regulatory approval.
Responsibilities
Reviewing Electronic IFU (Instructions for Use) submitted by Writers and Localization Team
Checking for issues on forms, asking questions of the Regulatory Affairs team, MES, Engineers, etc to ensure alignment in preparation for approval
Reviewing titles, productions, dates, models, pdfs to ensure correctness and alignment with the business unit
Detecting any IFUs that need to be removed before forwarding records to Regulatory Affairs for review and approval
Qualification
Required
Bachelor's degree with 2 to 5 years of experience
Masters if they have some of the experience needed
Equivalent of education and work experience
H.S. graduate with 2 to 5 plus years of experience
Data Entry
GDP (Good Documentation Practices)
Attention to detail
Excellent communication
Prioritization
Ability to identify urgent reviews
Previous writing, labeling or quality experience
Must be able to communicate outside of the small group
Company
Rangam
Rangam is a global, innovative, Total Talent management firm with the mission of accelerating meaningful employment for everyone! We are a minority-, woman-, and disability-owned firm with over 25 years of experience promoting sustainable and inclusive talent programs within our communities and employers.
H1B Sponsorship
Rangam has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (2)
2023 (4)
2022 (5)
2021 (4)
2020 (9)
Funding
Current Stage
Late StageCompany data provided by crunchbase