Company: Life scanners Healthcare Pvt. Ltd. (DigiPath AI)
Job Title: Regulatory & Documentation Specialist — Medical Devices
Location: Remote (Part time)
Role Overview:
Life Scanners Healthcare Pvt Ltd (DigiPath AI) builds AI-powered cancer screening devices, with a portfolio spanning CDSCO approvals, CE marking, and international device registration. India's CDSCO is our primary regulator, and it's the core of this role — international pathways (CE marking / EU MDR / US FDA) sit alongside it, not in place of it.
We're starting this engagement as an independent consultant arrangement rather than a full-time hire on day one. The idea is simple: work with us, get a feel for the portfolio and how we operate, and if it's a strong mutual fit, we'll talk about a full-time role. You'll work alongside our in-house team, who are already progressing CDSCO filings — your job is to bring dossier-level expertise and independent ownership to that effort, not starting from zero.
Key Responsibilities:
- Independently prepare, file, and track regulatory submissions on the CDSCO SUGAM portal
- Own compliance documentation across our product portfolio — Technical Files, Device Master Files, Clinical Evaluation Reports, and Post-Market Surveillance Reports
- Work alongside our in-house regulatory team to review, validate, and move existing CDSCO filings forward
- Liaise directly with regulatory consultants, notified bodies, and government agencies on our behalf
Qualifications & Experience:
- Background in pharma or MedTech regulatory affairs, with CDSCO as the core strength
- Hands-on experience with CDSCO submissions and MDR 2017 (Indian Medical Device Rules) — not just theoretical knowledge
- Working knowledge of ISO 13485 quality management basics (deep QMS expertise not required)
- Familiarity with import/export regulations and BIS certification processes is a plus
- CE marking / EU MDR or US FDA 510(k) exposure is a plus, but secondary to CDSCO depth
- India-based, comfortable owning dossiers end-to-end with minimal supervision
- Open to starting as an independent consultant, with interest in a longer-term relationship if it's a good fit
- Work directly with the founder and in-house team on a live device portfolio
Pay: ₹200,000.00 - ₹400,000.00 per year
Work Location: Remote
