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FLOAID MEDTECH PRIVATE LIMITED
Job Description — Chief Operating Officer (COO)
Company: Floaid Medtech Private Limited
Position: Chief Operating Officer (COO)
Location: Chennai, Tamil Nadu (onsite, no WFH), Indian and Overseas travel required.
Stage: Prototyping → Commercialization
Products: Heart-Lung Machine (HLM) & Catheter Pump (Cath Pump)
Device Class: Class C & Class D (CDSCO) | High-Risk Cardiac Devices
Experience: Minimum 15 Years | Preferably 40–50 Years of Age
Compensation: As per market standards (Fixed + Variable) + ESOP Eligibility
JD Date: April 2026
About Floaid Medtech
Floaid Medtech Private Limited is an early-stage, deep-tech medical device company building India’s first indigenous cardiac life-support devices — a Heart-Lung Machine (HLM) and a Catheter Pump (Cath Pump). Both are classified as Class C and Class D devices under CDSCO regulations, placing them among the most complex, high-stakes devices in the global medtech landscape.
Currently in the advanced prototyping phase, Floaid is backed by the Filatex Group (₹4,000 Cr+ turnover), aligned with the Make in India vision, and positioned as a homegrown alternative to global cardiac device majors. The company operates with a 15-member technology team based in Chennai, led by a CEO.
- Roles & Responsibilities
Regulatory Strategy & Approval — Non-Negotiable Core
• Own and drive end-to-end CDSCO regulatory strategy for Class C and Class D devices — from dossier preparation to DCGI approval and post-market surveillance.
• Lead engagement with CDSCO, and ethics committees for clinical investigation permissions and device approvals.
• Develop clinical evaluation and performance testing plans in coordination with the CEO and clinical partners.
• Map and execute pathways for ISO 13485, ISO 14971 (risk management), IEC 60601 series, and relevant harmonised standards.
• Evaluate and plan for CE marking and US FDA 510(k)/PMA as medium-term milestones.
• Build and maintain regulatory intelligence — track CDSCO MDR 2017 amendments, upcoming class-specific guidelines, and global equivalence frameworks.
2. Prototyping-to-Commercialization Transition
• Partner with the CEO to define and execute the Design Freeze → Verification & Validation → Clinical Trials → Commercial Launch roadmap.
• Drive design history file (DHF), device master record (DMR), and technical documentation to the standards required for regulatory submission.
• Build the quality management system (QMS) from scratch — SOPs, CAPA, complaint handling, vigilance reporting — aligned to ISO 13485.
• Establish test lab partnerships, notified body relationships, and clinical study site agreements.
• Identify and onboard contract manufacturers or manufacturing partners for scale-up.
3. Commercial Strategy, Go-To-Market & Revenue Ownership
• Own and develop the comprehensive go-to-market (GTM) strategy for both HLM and Cath Pump — product positioning, pricing architecture, channel strategy, distributor agreements, and KOL engagement plans.
• Define market segmentation and entry sequencing — government hospitals, AIIMS/PGIMER-tier institutions, private super-specialty cardiac centres, and defence/PSU healthcare systems.
• Build the institutional sales pipeline and lead hospital-level negotiations — clinical adoption conversations, procurement processes, and tendering.
• Lead government liaison efforts — PMBJP, MoHFW empanelment, state health scheme participation, and national procurement frameworks (GeM, DGS&D).
• Own P&L from commercialization — revenue targets, margin structure, distributor margins, and contribution per unit sold.
• Build, hire, and lead the commercial team from the ground up — regulatory affairs managers, institutional sales leads, and hospital account managers.
4. Investor Relations, Fundraising & Government Grants
• Build and maintain investor-ready pitch decks, financial models, and business plan documents — capable of articulating Floaid’s value proposition, technology moat, regulatory milestones, and revenue potential to institutional investors, family offices, and strategic partners.
• Lead investor presentations and roadshows — present Floaid’s story compellingly, handle deep-dive Q&A on regulatory, commercial, and financial dimensions, and negotiate term sheets in partnership with the CEO.
• Identify, apply for, and manage government grants, funding schemes, and incentive programmes — including DST, BIRAC (SBIRI / BIPP / BIG), DPIIT, Startup India Seed Fund, PLI schemes for medtech, and state-level innovation funds applicable.
• Drive applications and compliance for government-backed schemes such as NIDHI, Make in India medtech incentives, and any CDSCO / NPPA programmes relevant to indigenously developed cardiac devices.
• Build and maintain structured investor communication — quarterly milestone updates, cap table management support, and board-level reporting in coordination with the CEO.
• Liaise with legal, financial advisors, and the Filatex Group’s corporate team on due diligence, shareholder agreements, and fundraising documentation.
5. Operations, Finance & Governance
• Set up and oversee supply chain, procurement, and inventory for both prototype and commercial phases.
• Manage finance, accounts, legal, and HR functions — build the organizational infrastructure required for a scaling medtech company.
• Establish KPIs, performance dashboards, and governance rhythms across all functions.
• Be accountable for burn rate, capex deployment, and financial planning in partnership with the CEO and Filatex Group.
6. Stakeholder Management & External Liaising
• Represent Floaid at industry forums, regulatory consultations, cardiac surgery congresses, medtech associations, and investor events.
• Build and maintain relationships with cardiac surgeons, perfusionists, ICU specialists, hospital procurement heads, and clinical KOLs.
• Liaise with Filatex Group leadership and external investors — provide structured milestone updates, manage expectations, and maintain confidence during the prototyping-to-launch phase.
• Build relationships with government bodies — Ministry of Health, CDSCO, state health departments, DPIIT, BIRAC, and DST offices relevant to medtech innovation.
Candidate Profile — What We Are Looking For The Non-Negotiables
• ✦ Has personally driven commercialization of at least one Class C or Class D medical device — from working prototype to CDSCO approval and first commercial sale.
• ✦ Minimum 15 years of progressive experience in medtech / medical devices (not pharmaceutical), with at least 5 years in a senior cross-functional leadership role.
• ✦ Hands-on knowledge of CDSCO MDR 2017, Clinical Investigation regulations for high-risk devices, and DCGI submission processes.
• ✦ Has built regulatory, quality, or clinical affairs functions — not just managed them.
• ✦ Has built or contributed to investor pitch decks, participated in fundraising processes, and can present a company’s story, strategy, and financials credibly to investors.
• ✦ Has developed and owned a go-to-market strategy for a regulated medical device — not just executed someone else’s plan.
Strongly Preferred Profile
• Experience in cardiac devices, life-support equipment, perfusion systems, or Class D implantable/active devices.
• Has operated in a startup, early-stage, or greenfield medtech environment — able to work without established systems, build processes, and tolerate ambiguity.
• Exposure to government grant applications — BIRAC, DST, DPIIT, Startup India, or PLI-medtech schemes — and ability to manage compliance obligations post-grant.
• Exposure to both B2G (government institutional) and B2B (private hospital) sales in India.
• Familiarity with ISO 13485, ISO 14971, IEC 60601 compliance frameworks and international regulatory pathways (CE / FDA).
• Engineering or life sciences academic foundation with an MBA — or equivalent demonstrated competence.
Leadership & Personal Attributes
• Builder mentality — comfortable working with zero legacy infrastructure, defining the playbook from scratch.
• Operator-owner mindset — takes accountability for outcomes, not just activities.
• High scientific literacy — able to engage deeply with the CEO on device design, testing, and clinical evidence without being a technical expert.
• Decisive under uncertainty — makes calls, moves fast, course-corrects without defensiveness.
• Gravitas to represent Floaid with surgeons, government officials, investors, and group leadership.
Target Hiring Segments
The ideal candidate will most likely be found in one of the following backgrounds:
• Class C / Class D Medtech companies operating in cardiac, vascular, neurology, or life-support domains in India or globally.
• R&D-to-Market transition roles in MNCs such as Getinge, LivaNova, Terumo, Edwards Lifesciences, Medtronic, Abbott, or Indian equivalents.
• Regulatory Affairs / Clinical Affairs leaders who have crossed into General Management or Operations.
• Medtech startup operators who have taken devices through CDSCO high-risk approval pathways.
• NOT preferred: Pure commercial / sales profiles without device development or regulatory exposure; pharma backgrounds without device-specific experience.
Education
• B.E. / B.Tech / B.Sc. (Engineering, Biomedical Engineering, Life Sciences, or related) — strongly preferred as foundational base.
• MBA / PGDM from a reputed institution — preferred but not mandatory if demonstrated track record compensates.
• Certifications in Regulatory Affairs (RAC), QMS Lead Auditor (ISO 13485), or Clinical Research are a strong plus.
Floaid Medtech Private Limited | Chennai, Tamil Nadu | floaid.com
Backed by the Filatex Group | April 2026 | Confidential — For Recruitment Purposes Only
