I am a Life Science Sales & Recruiting Professional with 10 years of experience providing strategic consulting and project-based statement of work solutions, services, and resources in the Medical Device, Bio/Pharmaceutical, and CDMO industries.The bulk of my experience has been supporting GxP Compliance initiatives for my client partners.I have supported numerous Medical Device clients and projects ranging across Class I-III devices, start-ups and New Product Introductions, to Sustaining Engineering of existing legacy products. I have provided remediation services and resources to clients addressing FDA/EU regulation changes/updates, Warning Letters, 483s, Recalls, and Consent Decree.I have supported numerous Bio/Pharma clients ranging from pre-clinical to commercial. I have assisted clients with the services and resources needed implement a QMS, commission/qualify/validate equipment, facility, and utilities, validate computer systems needed for clinical and commercial manufacturing, and review and approve manufacturing batch records, deviations, investigations, CAPA, Change Controls, and SOPs. In addition to this I have supported clients with EU MDR, Regulatory submissions, Tech Transfers, and Supplier Audits, along with many other projects.Compliance / Quality / Regulatory / CQV / CSV / V&V / Design Assurance / CAPA / MDR / EU MDR / GxP / GMP / GCP