Biomedical Quality

Biomedical Quality & Regulatory ManagerAbout Taurean Surgical

Taurean Surgical builds affordable, AI-enabled surgical visualization and data platforms (CELEST console, surgical exoscope, and a secure SaaS for capture, streaming, analytics). We democratize access to precision surgery for hospitals in India and emerging markets while meeting global quality and safety bars.

Role overview

You will own our Quality Management System (QMS) end-to-end and lead regulatory strategy and submissions across India and select global markets. This is a hands-on role covering hardware (electro-medical), SaMD (software as a medical device), cybersecurity, and clinical/performance evidence. You'll partner closely with R&D, manufacturing, clinical, and commercial teams to ship compliant products on time.

Title:
 Biomedical Quality & Regulatory Manager

Location:
 Hyderabad (preferred) — hybrid/flexible

Reports to:
 COO/CEO

What you will own

• QMS leadership:
   Implement, maintain, and continuously improve a certifiable QMS aligned to 
  ISO 13485
   and India MDR; drive document control, training, internal audits, KPIs.
• Risk & safety:
   Lead 
  ISO 14971
   risk management (hazard analysis, FMEA/FTA), 
  IEC
   safety & EMC planning with test labs, and 
  IEC
   usability engineering.
• SaMD & software lifecycle:
   Establish 
  IEC 62304
   processes (classification, SDLC, SOUP, cybersecurity), and 
  ISO/IEC 27001/IEC
   aligned security controls; handle 21 CFR Part 11 where applicable.
• Regulatory strategy & submissions:
• India (CDSCO):
   Device classification, test licenses, import/manufacture licenses, predicates, eGSDL/online portal submissions, labeling/UDI, vigilance.
• US/EU (as applicable):
   510(k)/De Novo strategy, 
  EU MDR 2017/745
   Technical Documentation, clinical/performance evaluation, PMS/PMCF planning.
• Manage Notified Body/FDA interactions and respond to queries.
• Design & technical files:
   Own DHF/Technical File, DMR/DMR-S, traceability (URS → risk → verification → validation), change control, and configuration management.
• Verification/Validation:
   Plan & execute V&V (bench, software, electrical, environmental), usability studies, and clinical/performance evaluations with KOL sites.
• Manufacturing quality:
   Incoming inspection plans, supplier quality (SCARs), process validation (IQ/OQ/PQ), calibration, NC/CAPA, complaint handling, field actions/recalls readiness.
• Post-market & surveillance:
   PMS plan, signal detection, vigilance reporting to CDSCO/FDA/Competent Authorities; periodic safety updates; reliability & incident trend analysis.
• Data protection & interoperability:
   Align to India 
  DPDP Act
  , HIPAA (if applicable), DICOM/HL7-FHIR data workflows; labeling/eIFU and multilingual compliance.
• Audit readiness:
   Lead internal audits; host external/Notified Body/authority inspections; close findings with sustainable CAPA.

Must-have qualifications

• Experience in Quality/Regulatory for medical devices; experience with electro-medical and/or SaMD.
• Proven implementation/maintenance of 
  ISO 13485
   QMS and ownership of 
  ISO 14971
   risk files.
• Hands-on with 
  IEC 62304
   (software safety class B/C) and cybersecurity documentation.
• India 
  CDSCO/MDR 2017
   submissions experience (Class B/C/D preferred).
• Strong command of DHF/DMR, change control, validations (IQ/OQ/PQ), NC/CAPA, complaints/vigilance.
• Excellent cross-functional leadership, writing, and regulator-facing communication.

Nice-to-haves

• US 
  510(k)/De Novo
   or 
  EU MDR
   Technical Documentation experience.
• Exposure to 
  IEC /-1-2
   testing, 
  
   usability, 
  
   (health software).
• Hospital/clinical study operations, GCP/ethics submissions.
• Start-up manufacturing scale-up, supplier quality in India; familiarity with BIS standards.
• Certifications: Lead Auditor 
  ISO 13485/9001
  , RAC, CQE/CQA.

KPIs you'll drive

• QMS certification readiness (green by target date)
• Submission acceptance rate & time-to-clearance
• Audit/inspection outcomes (0 major NCs)
• CAPA effectiveness & closure lead time
• Complaint rate, vigilance timeliness, PMS signal closure
• On-time V&V completion and release readiness

Tools & standards (we use/expect)

• QMS/eQMS & DMS (e.g., Greenlight Guru, Qualio, or equivalent), Jira, Git, TestRail
• Statistical tools (Minitab/R); requirements & traceability tools
• Core standards/regulations: 
  ISO 13485, ISO 14971, IEC 62304, IEC /-1-2, IEC , EU MDR 2017/745, India MDR 2017, 21 CFR 820/QMSR, 21 CFR Part 11, IEC , ISO/IEC 27001, DPDP Act (India), HIPAA (as applicable)

What we offer

• Mission-driven work impacting surgical safety and access
• Ownership from day one; fast path to Head of Quality & Regulatory
• Competitive salary, flexible/hybrid work; KOL & hospital network access

How to apply:
 Send your CV + 1–2 representative submission/QMS artifacts (blinded) to