Highbrow LLC
Senior Validation Consultant
Highbrow LLC, Trenton, New Jersey, United States,
Job Title: Senior Validation ConsultantJob ID: 2022-11351
Job Location: Somerset, NJ
Job Travel Location(s):
# Positions: 1
Employment Type: W2
Candidate Constraints:
Duration: Long term
# of Layers:0
Work Eligibility:All Work Authorizations are Permitted – No Visa Transfers
Key Technology:
infrastructure software, medical device software
Job Responsibilities:
Review SDLC, validation documentation and propose remediations in line with regulatory requirements – business applications, infrastructure software, Medical Device Software
Verify all design control/validation artifacts for completion and accuracy
Coach teams when required to ensure adherence to internal process and regulatory requirements
Ensure all documentation for regulatory submissions are in order by closely working with the technical as well as quality and compliance and regulatory affairs teams
Skills and Experience Required:
10-12 years’ experience in validation of business applications (ERP, LIMS, etc), infrastructure software and Medical Device Software
Proficient with FDA regulations and standards, including GxP regulations, 21 CFR 820.30 Medical Device Design Controls, ISO 13485, ISO 14971, ISO 62304, ISO 82304. Specific experience with Medical Device Software required
Should have experience authoring SOPs, Work Instructions, Templates in alignment to Quality Management System (QMS).
Demonstrated experience in remediating the Design Control Process and validating artifacts produced through the Medical Device Software Development Life Cycle that are required to be produced for regulatory submissions
Experience in 510(k) process preferred
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Job Location: Somerset, NJ
Job Travel Location(s):
# Positions: 1
Employment Type: W2
Candidate Constraints:
Duration: Long term
# of Layers:0
Work Eligibility:All Work Authorizations are Permitted – No Visa Transfers
Key Technology:
infrastructure software, medical device software
Job Responsibilities:
Review SDLC, validation documentation and propose remediations in line with regulatory requirements – business applications, infrastructure software, Medical Device Software
Verify all design control/validation artifacts for completion and accuracy
Coach teams when required to ensure adherence to internal process and regulatory requirements
Ensure all documentation for regulatory submissions are in order by closely working with the technical as well as quality and compliance and regulatory affairs teams
Skills and Experience Required:
10-12 years’ experience in validation of business applications (ERP, LIMS, etc), infrastructure software and Medical Device Software
Proficient with FDA regulations and standards, including GxP regulations, 21 CFR 820.30 Medical Device Design Controls, ISO 13485, ISO 14971, ISO 62304, ISO 82304. Specific experience with Medical Device Software required
Should have experience authoring SOPs, Work Instructions, Templates in alignment to Quality Management System (QMS).
Demonstrated experience in remediating the Design Control Process and validating artifacts produced through the Medical Device Software Development Life Cycle that are required to be produced for regulatory submissions
Experience in 510(k) process preferred
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