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RA Lead at Happy Reliable Surgeries Pvt Ltd (HRS Navigation) · Bengaluru (Bangalore) · 7 - 15 years · ₹10L - ₹20L / yr · Profitable · Posted 22 Sep 2026

7 - 15 yrs
₹10L - ₹20L / yr
Bengaluru (Bangalore)
Skills
Regulatory affairs
Documentation

20RA Lead (7–8 years) | EU MDR + India (CDSCO) | Medical Devices

Role summary

Lead regulatory strategy and submissions for a medical device portfolio (hardware + software + accessories) across the EU MDR and India (CDSCO), with strong ownership of technical documentation and lifecycle change management.

Key responsibilities

  • Own regulatory strategy and submission planning for EU MDR + India; build timelines, evidence plans, and dossier readiness trackers.
  • Lead/author EU MDR Technical Documentation (Annex II & III): device description, GSPR checklist, risk/benefit, V&V summaries, clinical evaluation linkage, labeling/IFU, PMS/PMCF plans.
  • Drive classification and portfolio mapping; support UDI basics and EMDN/basic UDI alignment (as applicable).
  • Manage Notified Body interactions: questions, responses, meeting preparation, evidence packaging, and change justifications.
  • Own India lifecycle activities: CDSCO changes (PAC), license maintenance, and regulatory communications.
  • Ensure regulatory alignment for standards-driven evidence: ISO 14971, IEC 62304, IEC 60601, IEC 81001-5-1, usability (IEC 62366-1), biocompatibility (ISO 10993), and sterilization/reprocessing (as applicable).
  • Support labeling/claims governance: intended use, indications, contraindications, and marketing claims review.
  • Build and mentor the RA team; ensure version control, traceability, and audit-ready submissions.

Must-have qualifications

  • 7–8 years in regulatory affairs for medical devices (Class II/III exposure preferred).
  • Strong experience with EU MDR technical documentation and handling Notified Body queries/submission packages.
  • Working experience with the CDSCO regulatory lifecycle (licenses/changes) is strongly preferred.
  • Solid understanding of standards-driven evidence for HW+SW devices (14971, 62304, 60601, usability, biocomp).

Nice to have

  • Exposure to US FDA 510(k), clinical evaluation/PMCF, cybersecurity documentation, and SaMD claims strategy.
  • Experience with complex HW+SW systems and regulated accessories/instruments.

 


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About Happy Reliable Surgeries Pvt Ltd (HRS Navigation)

Founded :
2015
Type :
Product
Size :
20-100
Stage :
Profitable

About

Happy Reliable Surgeries Pvt Ltd (HRS Navigation) started in 2015. It is India's first and only company to develop high tech surgical navigation system for highly complex Brain & Spine surgeries. Our products directly compete with world’s biggest medical devices companies. We are proudly one of the few global companies who have capabilities to develop Computer assisted and Robotic Assisted surgeries products. R&D Centre is based at Bangalore. It has been started by Ex of a global medical device company. It has been incubated & mentored by IIM Calcutta.

 

Why Do We Exist: - Currently all hi-tech medical devices are imported. Which leads to very high cost of healthcare & non reachability to common people. Our Purpose is to make premium healthcare affordable & accessible by continuous innovation for our people. We want to make India Proud.

 

Our Achievements: -

  • 10 Best start-up in Medical Devices (Insight Success Magazine)
  • Won Top 50 emerging product start-up NASSCOM 2017 (National Award)
  • Winners in Economic Power of Ideas award 2018 (IIM Ahmadabad) (National Award)
  • Winners in Smart Fifty competition conducted by IIM Calcutta (National Award)
  • Won Elevate 100, Karnataka top 100 company (State Award from Karnataka Government)
  • Grown Exponential even in 2020 financial Year. (No Salary Cuts / Firings)
  • 3000+ successful Surgeries performed by our products.
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Connect with the team

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Aanchal Jain

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Technical Product Manager – Healthcare

Required Experience

  • 5+ years in technology product or platform product roles.
  • Demonstrated experience delivering healthcare technology products.
  • Direct exposure to healthcare data, analytics, or AI-enabled solutions.
  • Experience operating in regulated environments, including HIPAA, PHI, and healthcare compliance.
  • Proven ability to lead complex healthcare initiatives through ambiguity and change.

Healthcare Domain Expertise

  • Strong understanding of healthcare operations and workflows, including:
  • Payer
  • Provider
  • Care Management
  • Familiarity with healthcare domains such as:
  • Utilization Management (UM)
  • Care Management / Case Management
  • Prior Authorization
  • Ability to translate clinical and operational workflows into scalable technology solutions.
  • Strong understanding of regulatory, compliance, and patient safety considerations in product decisions.

Product & Strategy

  • Outcome-driven product mindset grounded in healthcare realities and AI/data-first thinking.
  • Ability to identify where data, analytics, and AI can improve healthcare outcomes or reduce administrative burden.
  • Roadmap ownership integrating:
  • Core healthcare capabilities
  • Data and interoperability foundations
  • Analytics and AI enablement
  • Prioritization informed by:
  • Clinical impact
  • Operational value
  • Feasibility
  • Risk
  • Strong problem framing focused on insight generation, automation, and scale.

Data, Analytics & AI Enablement

  • Working understanding of:
  • Healthcare data domains, including member, provider, clinical, authorization, and outcomes data.
  • Data flows across payer, provider, and partner systems.
  • Ability to partner with Data Engineering, Analytics, and AI teams to:
  • Enable reliable healthcare analytics and reporting.
  • Support decision-making through insights and AI-assisted summarization.
  • Experience defining requirements for:
  • Operational and clinical dashboards.
  • KPIs tied to quality, efficiency, cost, and experience.
  • AI-enabled analytics, including summarization, prioritization, and decision support.
  • Awareness of data quality, lineage, interoperability, and adoption challenges in healthcare.

AI & Automation in Healthcare

  • Understanding of AI use cases relevant to healthcare:
  • Clinical and operational summarization.
  • Decision support with human-in-the-loop.
  • Workflow automation and prioritization.
  • Ability to balance innovation with:
  • Responsible AI practices.
  • Explainability and auditability.
  • Regulatory and ethical considerations.
  • Experience guiding AI from pilot to production to scaled adoption in healthcare settings.

Technology & Architecture Knowledge

  • Understanding of modern architectures supporting healthcare data and AI:
  • APIs
  • Microservices
  • Cloud platforms
  • Data platforms
  • Interoperability layers
  • Integration patterns
  • Ability to evaluate build vs. buy vs. reuse with healthcare constraints in mind.
  • Comfort navigating legacy systems, technical debt, and complex integrations common in healthcare ecosystems.

Delivery & Execution

  • Agile / SAFe execution with emphasis on progress, readiness, and adoption.
  • Strong dependency and risk management across:
  • Product teams
  • Data pipelines
  • Analytics platforms
  • AI platforms
  • Release planning that includes:
  • Data readiness and validation.
  • Analytics accuracy.
  • AI model monitoring.
  • Compliance checks.

Stakeholder & Communication

  • Trusted partner to business, clinical, and operations leaders.
  • Clear articulation of trade-offs, risks, and value realization.
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Shubham Vishwakarma

Full Stack Developer - Averlon
I had an amazing experience. It was a delight getting interviewed via Cutshort. The entire end to end process was amazing. I would like to mention Reshika, she was just amazing wrt guiding me through the process. Thank you team.
Companies hiring on Cutshort
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