RC-REGULATORY COMPLIANCE-CSV-Quality Lead SaMD-Senior

At EY were all in to shape your future with confidence. Well help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. EY- GDS Consulting Enterprise Risk - ER Regulatory Compliance Senior SaMD SME - Quality Consultant As part of our EY-ER- Regulatory Compliance team you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish maintain and strengthen internal and external line with our commitment to quality youll consistently drive projects to completion with high quality deliverables achieve operational efficiency proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We are seeking a highly experienced and detail oriented SaMD GxP Quality Consultant with strong expertise in Software as a Medical Device (SaMD) quality governance validation and regulatory compliance within GxP regulated and quality critical environments. The ideal candidate will ensure the safety reliability integrity and regulatory readiness of SaMD solutions while partnering with cross functional teams to establish implement and sustain inspection ready compliant digital health systems. This role is responsible for leading SaMD quality and validation activities across the full product lifecycle including requirements definition risk management design controls validation planning deployment readiness and post market change management in alignment with GxP principles risk based validation and data integrity addition the consultant will own and manage SaMD lifecycle documentation and templates including SOPs work instructions validation templates and standardized quality artifacts ensuring consistency traceability and regulatory compliance across programs. The consultant will play a key role in embedding Quality by Design governance by design and lifecycle documentation controls enabling the safe compliant and transparent use of SAMD solutions within regulated life sciences and pharmaceutical environments. Your key responsibilities Lead SAMD quality and validation activities across the full lifecycle including requirements definition risk management design controls deployment readiness and post market change management.Own and maintain SAMD quality documentation and templates including SOPs work instructions validation templates and lifecycle artifacts to ensure standardization and reuse.Establish and enforce risk based validation and Quality by Design (QbD) principles aligned with GxP expectations.Ensure SAMD solutions remain inspection ready through controlled documentation traceability versioning and audit evidence management.Provide quality governance and oversight for SAMD initiatives reviewing and approving lifecycle deliverables for compliance and consistency.Support regulatory inspections audits and assessments by maintaining compliant procedures templates and evidence repositories.Partner with cross functional teams (product engineering regulatory quality) to embed governance by design across SAMD programs.Coach and guide project teams on proper usage of templates documentation expectations and quality standards. Qualifications: Bachelors or masters degree in Life Sciences Engineering or related field.5 years of experience in SAMD and SIMD domain software testing validation or quality engineering roles.Experience creating user stories test scripts and validation deliverables (e.g. Validation Plans Traceability Matrix).Exposure to cloud ecosystems such as Azure AWS or GCP.Consulting or clientfacing experience preferred.Excellent communication documentation and stakeholder management skills. Must-Have Skills & Attributes Strong knowledge of SAMD / SaMD regulatory and quality expectations including FDA SaMD guidance GxP GAMP 5 and Data Integrity (ALCOA).Proven experience managing SAMD lifecycle documentation procedures SOPs and validation templates.Expertise in risk based validation design controls and lifecycle quality governance.Detail oriented mindset with strong documentation review and approval rigor.Ability to operate independently as a process and template owner in complex regulated environments.Strong stakeholder management and communication skills with the ability to guide teams on quality and compliance expectations.Strong knowledge of GxP regulations (FDA 21 CFR Part 11 EU Annex 11)GAMP 5 methodology and system development life cycle (SDLC)CSV documentation: URS FRS IQ/OQ/PQ Traceability Matrix Validation PlansUnderstanding of data integrity principles and electronic records/e-signatures complianceAbility to collaborate with cross-functional teams (QA IT Manufacturing Labs)Experience in client-facing roles managing expectations and delivering solutionsStrong communication and At EY were