onsite
Technical Lead - Pharma Compliance, Quality & Regulatory - CitiusTech
Engineering Manager
Lead regulatory and compliance efforts for healthcare software, driving FDA 510(k) and EU MDR documentation, GAMP 5 risk‑based validation, and Part 11 data integrity across cloud, on‑premise, and web platforms.
About the role
Key Responsibilities
- Own the end‑to‑end regulatory documentation lifecycle for HLS software, ensuring alignment with FDA 510(k) and EU MDR Annex II/III requirements.
- Guide engineering teams through GAMP 5 risk‑based validation, data integrity, and Part 11 compliance, producing audit‑ready evidence.
- Collaborate with QA, Clinical, and Product teams to embed regulatory controls into product design and release processes.
- Maintain up‑to‑date knowledge of evolving regulatory frameworks and industry best practices.
- Lead cross‑functional reviews, audits, and corrective actions to sustain regulatory readiness.
Requirements
- 7–10 years of experience in regulatory compliance for healthcare or life‑sciences software.
- Deep expertise in FDA 510(k), EU MDR, GAMP 5, Part 11, and data integrity principles.
- Proven track record of delivering regulatory documentation and validation artifacts.
- Strong communication skills and ability to mentor technical teams.
- Experience with cloud‑based and on‑premise healthcare applications is a plus.
Skills
software developmentsystem designproblem solving