About this role
Senior consultant to lead MedTech QMS complaints implementations, guiding life sciences customers through regulatory-compliant transformations and ongoing optimization of complaint handling, CAPA, and risk processes.
Key Responsibilities
- Lead QMS Complaints implementation workstreams
- Primary customer liaison
- Analyze requirements and feature adoption roadmaps
- Guide customers in Vault and best practices
- Manage post-implementation continuous improvement
Technical Overview
Hands-on QMS/ gxp focused consulting for medical devices; regulatory requirements; SaaS-based QMS implementations; data/content management and vault platform familiarity.
Ideal Candidate
The ideal candidate is a senior life sciences quality professional with 8+ years of GMP/QA experience, deep knowledge of QMS/Complaints across medical devices, and strong regulatory acumen for FDA EU MDR/IVDR requirements. They should excel in client-facing consulting, balancing strategic advisory with hands-on implementation guidance.
Must-Have Skills
8+ years of experience in GMP Systems ownership or Software Consulting5+ years of experience in Complaints Management for Medical DeviceStrong understanding of FDAEU MDR/IVDR requirements and ReportingUnderstanding of relationship between Complaint HandlingCAPANonconformance and Risk Management processesKnowledge of ISO 13485 and 14971FDA 21CFR Part 803820822806EU GMP Annex 11Proven track record leading implementation and/or IT operations as a consultantbusiness analystor IT lead and/or business sponsorProven ability to work both independently and in teams in a dynamicfast-moving environmentGood understanding of SaaS and GxP principlesAbility to quickly understand business requirements and design creative solutionsExcellent verbal and written communication skillsExperience in the Life Sciences QualityManufacturingor Healthcare spacesExperience with Data or Content Management applications
Nice-to-Have Skills
Veeva Vault implementation experienceManagement ConsultingChange Management experienceField Action and Product Return experienceClinical Medical DeviceBiologicsand SaMD experience
Tools & Platforms
Veeva Vault
Required Skills
GMP Systems ownership; Software Consulting; Complaints Management for Medical Device; FDA; EU MDR/IVDR; CAPA; Nonconformance; Risk Management; ISO 13485; ISO 14971; FDA 21 CFR Part 803820822806; SaaS; GxP; Veeva Vault; Data or Content Management applications
Hard Skills
GMP Systems ownershipSoftware ConsultingComplaints Management for Medical DeviceFDAEU MDR/IVDRCAPANonconformanceRisk ManagementISO 13485ISO 14971FDA 21 CFR Part 803820822806SaaSGxPVeeva VaultData or Content Management applications
Soft Skills
excellent verbal and written communicationindependent and in teamsleadershipcustomer focusproblem solving
Keywords for Your Resume
medtechqms complaintscomplaints managementgmpfdaeu mdrivdrcapanonconformancerisk managementiso 13485iso 14971fda 21 CFR Part 803fda 21 CFR Part 820fda 21 CFR Part 822fda 21 CFR Part 806eu gmp annex 11veeva vaultlife sciencesquality management systemsaasgxPdata or content management applicationsmedical devicefield actionproduct returnclinical saMDhealthcare spaces
Deal Breakers
Lack of 8+ years GMP/QA experience, No experience with medical device complaints, No familiarity with ISO 13485 / ISO 14971
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