Back to jobsStrong 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
