Chief Operating Officer (COO)

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