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

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 relationships. In line with our commitment to quality, you’ll 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 expectations. In 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:

• Bachelor’s or master’s 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 client‑facing 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 Plans
• Understanding of data integrity principles and electronic records/e-signatures compliance
• Ability to collaborate with cross-functional teams (QA, IT, Manufacturing, Labs)
• Experience in client-facing roles, managing expectations and delivering solutions
• Strong communication and presentation skills
• Experience in IT project management and validation planning
• Ability to troubleshoot application issues and recommend solutions
• Familiarity with change control, deviation handling, and CAPA processes
• Proven ability to mentor junior staff and lead validation teams
• Experience in training and cross-skilling resources
• Strong teamwork and collaboration mindset

Good-to-Have Skills & Attributes

• Exposure to medical device software standards such as IEC 62304, ISO 13485, ISO 14971.
• Experience supporting digital health, AI/ML enabled SAMD, or data driven medical software from a quality standpoint.
• Familiarity with post market surveillance, change impact assessments, and regulatory submissions support.
• Experience working in global or multi site quality governance models.
• Consulting or client facing experience within regulated life sciences programs
• Exposure to business development activities and client engagement strategies
• Ability to create innovative insights and contribute to thought leadership
• Understanding of market trends and competitor landscape
• Experience in process optimization and operational efficiency initiatives
• Ability to align technology with business transformation goals
• High attention to detail and analytical thinking
• Adaptability to changing regulatory and business environments
• Strong problem-solving and decision-making abilities

What we look for

• A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills.
• An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide.
• Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries

What working at EY offers

At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are.

You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer:

• Support, coaching and feedback from some of the most engaging colleagues around
• Opportunities to develop new skills and progress your career
• The freedom and flexibility to handle your role in a way that’s right for you