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 solid 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.
- Prepare documentation aligned with the EU MDR Annex II/III technical documentation structure, including system description,



design development evidence, VV summaries, risk management traceability, and labeling/IFU inputs.
- 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.
- 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.
- 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

📌 Technical Lead (Pune)
🏢 CitiusTech
📍 Pune