"Serve as the hands‑on Regulatory & Compliance Lead for Healthcare & Life Sciences (HLS) software products—covering cloud-based, on‑premise, and web applications. Own the complete regulatory‑compliance documentation lifecycle and guide engineering teams to produce regulatory‑grade, audit‑ready evidence. This role requires strong understanding of regulatory documentation frameworks used in FDA 510(k) submissions and EU MDR Annex II/III technical documentation, combined with hands‑on experience in validation, data integrity, Part 11/Annex 11, and GAMP 5 risk‑based compliance frameworks. Imaging domain knowledge is a strong plus" Key Responsibilities Regulatory Documentation Ownership Create, structure, and maintain all documentation required for HLS software regulatory submissions, including sections defined in FDA 510(k) submission guidelines such as software description, architecture, verification/validation, cybersecurity, and substantial equivalence analysis. [fda.gov] Prepare documentation aligned with the EU MDR Annex II & III technical documentation structure, including system description, design & development evidence, V&V summaries, risk management traceability, and labeling/IFU inputs. [fda.gov] Develop regulatory checklists for cloud and non‑cloud software (SaaS/PaaS/IaaS, hybrid, and standalone apps). Compliance & Validation Leadership Lead creation of GxP/regulated system documentation following GAMP 5 risk‑based lifecycle guidance, ensuring traceability from URS design testing validation evidence release. [tuvsud.com] Implement & document controls for 21 CFR Part 11 (electronic records/signatures) and EU Annex 11 (computerized systems) including audit trails, security, data integrity (ALCOA+), and system lifecycle control. [gmp-compliance.org], [fda.gov] Create validation deliverables independently: URS, risk assessments, IQ/OQ/PQ protocols, test results, periodic review documentation, and change control validation impact assessments. Cross‑Functional Technical Guidance Work closely with engineering teams to help them produce regulatory‑ready artifacts, including but not limited to - Architecture diagrams Data flow & audit trail mapping Cybersecurity documentation for FDA submissions (per 510(k) guidance) Verification & validation evidence Risk mitigations tied to ISO 14971 Translate regulatory requirements into implementable tasks for developers and QA teams. Regulatory Readiness for Cloud & Web Platforms Guide teams on compliance expectations for: Cloud‑hosted HLS platforms Multi‑tenant SaaS architectures Deployed AI/ML features (if applicable) APIs, microservices, and data flows impacting regulated functions Ensure documentation aligns to software‑specific sections in 510(k) and EU MDR frameworks for devices/software. Audit & Inspection Preparedness Prepare audit‑ready documentation packages for internal QA, client assessments, and regulatory audits. Act as compliance SME during audits, leveraging knowledge of predicate rules and system validation frameworks defined under FDA Part 11 and EU Annex 11. Required Skills & Experience 8–14 years in regulatory, software compliance, CSV, or HLS technology roles. Deep practical knowledge of: FDA 510(k) submission structure & evidence expectations (software documentation, cybersecurity, V&V) [fda.gov] EU MDR Annex II/III technical documentation frameworks for software [fda.gov] 21 CFR Part 11 controls for e‑records/e‑signatures [gmp-compliance.org] EU Annex 11 for computerized systems (security, validation, data integrity) [fda.gov] GAMP 5 validation lifecycle and risk‑based approach [tuvsud.com] Strong understanding of SDLC, cloud architectures, and documentation needs for SaaS and regulated web apps. Ability to independently produce high‑quality regulatory content (not just review). Strong cross‑functional communication — able to guide engineers, QA, product, and security.
