Job Title:
HFE Operations / R&D Support Specialist (Hybrid)
Work Arrangement:
Hybrid schedule Work from Home on Monday & Friday, In-office TuesdayThursday
Work Hours: Standard business hours with some flexibility
Essential Duties & Responsibilities
Invoice & Payment Processing
Receive, log, review, and process invoices from US and Rest of World (ROW) external HFE vendors.
Coordinate invoice reviews with HFE Project Leads and obtain authorization prior to payment processing.
Process payments using multiple contract processing systems and Coupa.
Partner with Procurement to resolve payment-related issues, including vendor banking errors and overdue payments.
Vendor Contract Management
Draft and process vendor contracts for US and multiple global geographies.
Collaborate with Ethics & Compliance teams to meet region-specific compliance requirements.
Submit WWM review requests and obtain IRB approvals when required.
Support expansion of HFE contracting processes beyond US-only compliance to global regions.
Change Control & Impact Assessment Support
Receive and catalog HFE Impact Assessment (IA) requests for Change Controls.
Review IA requests with HFE Therapy Leads and complete assessments when required.
Identify and complete cases where HFE IA was incorrectly initiated.
Track, prioritize, and manage Change Controls that require HFE review.
Cross-Functional & Operational Support
Collaborate with HFE team members to evaluate vendor capabilities.
Work with Procurement to onboard new vendors and maintain internal supplier lists.
Support broader R&D teams with ordering supplies and equipment as needed.
Qualifications
Required Skills
Strong interpersonal, communication, and collaboration skills.
Ability to work independently, make decisions, and solve problems with minimal supervision.
Proficiency in Microsoft Office tools.
Proactive mindset with the ability to identify process gaps, recommend improvements, and implement solutions.
Education & Experience
High School Diploma or equivalent (required)
Bachelors degree preferred; some college coursework preferred
35 years of overall professional experience
5+ years of experience supporting technical teams, preferably within a Medical Device R&D environment | |
Contact Information
Email: aditya.sharma@gvrinfotek.com
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