ABOUT S3V VASCULAR TECHNOLOGIES LIMITED S3V Vascular Technologies Limited is an ISO 13485 certified company involved in the development and manufacture of Neurovascular, Cardiovascular Medical devices and Critical Care products such as Clot Retrievers, Neuro Aspiration Catheters, Neuro Micro-catheters, Neuro Guide catheters, Drug Eluting Stents, PTCA Catheters and drug coated critical care catheters. S3V is setting up an integrated manufacturing facility in Chennai at the Medical Device Park, Oragadam for the manufacture of Neuro interventional and peripheral interventional devices. With a strong focus on innovation, clinical safety, and regulatory compliance, we are committed to delivering cutting-edge solutions for critical care. Our manufacturing facilities are designed to meet global standards, including ISO 13485, and we are actively pursuing certifications under EU MDR, US FDA, and CDSCO guidelines JOB SUMMARY The Head of Regulatory Affairs (RA) is responsible for developing and executing regulatory strategies to obtain and maintain product approvals and licenses in India (CDSCO), the European Union (CE marking under MDR), and the United States (FDA 21 CFR Part 820). The role ensures that all Class III medical devices in interventional neurology, cardiology, and peripheral applications meet all applicable regulatory requirements for global market access. KEY RESPONSIBILITIES · Develop and execute regulatory strategies for CE marking (under EU MDR), US FDA approvals (510(k)/PMA), and CDSCO manufacturing and marketing authorizations. · Ensure timely preparation, submission, and maintenance of regulatory dossiers including Technical Files, Design Dossiers, and Device Master Files. · Act as primary contact with regulatory authorities (CDSCO, Notified Bodies, US FDA) and manage communications during audits, inspections, and submissions. · Oversee the creation, maintenance, and submission of all regulatory documentation to ensure compliance with global regulations. · Support product development teams to ensure regulatory requirements are embedded throughout the product lifecycle. · Monitor changes in international regulatory requirements and provide guidance to internal teams on compliance impacts. · Coordinate with cross-functional teams including Quality, R&D, Manufacturing, and Clinical Affairs to support regulatory submissions. · Ensure timely renewals, variations, and post-market reporting (e.g., vigilance reporting, adverse event notifications). · Lead regulatory due diligence and risk assessments for new product development and changes. · Manage and mentor the RA team to build internal regulatory competency. · Prepare for and support audits by regulatory authorities and notified bodies. · Ensure regulatory labeling, claims, and promotional materials comply with applicable laws and regulations. EDUCATION & EXPERIENCE · Master’s degree in Pharmacy, Engineering, Life Sciences, or related field. · 10+ years of experience in regulatory affairs within the medical device industry, including Class III devices. · Proven experience in obtaining CE certification under EU MDR and US FDA approvals (510(k), PMA). · Familiarity with CDSCO regulatory processes including site and product registrations. · Strong knowledge of global regulatory frameworks (EU MDR, US FDA, ISO 13485, Indian MDR 2017). · Experience with technical documentation, risk management (ISO 14971), and clinical evaluation reporting. . Strong interpersonal and communication skills to interface with regulators and internal stakeholders. KEY SKILLS · Strategic regulatory planning · Expert knowledge of medical device regulations · Regulatory submissions and dossier compilation · Strong written and verbal communication · Cross-functional leadership and collaboration . Project management and attention to detail
Company Description S3V Vascular Technologies aims to be a global leader in medical technology, enhancing the lives of patients with cardiovascular diseases. We work closely with healthcare professionals to create innovative medical technologies and deliver transformative therapies. Managed by a team of highly qualified professionals, our goal is to bring global best practices to the Indian healthcare market, focusing on developing medical devices, physician education, and patient awareness. We are committed to setting ambitious goals to become the market leader in all our focus areas. Role Description This is a full-time on-site role for a Polymer Engineer, located in Chengalpattu. The Polymer Engineer will be responsible for developing and optimizing polymer-based materials, conducting research and development (R&D) activities, and working on polymer extrusion processes. Day-to-day tasks will include designing experiments, analyzing data, collaborating with cross-functional teams, and staying updated with industry trends to ensure the development of cutting-edge medical technologies. Qualifications Expertise in Polymer Engineering, Polymers, and Polymer Science Experience in Research and Development (R&D) activities Knowledge of polymer extrusion processes Strong analytical and problem-solving skills Excellent communication and teamwork abilities Bachelor's or Master's degree in Polymer Engineering, Materials Science, or related field Experience in the medical device industry is a plus Ability to work effectively on-site in Chengalpattu
Company Description S3V Vascular Technologies aims to be a global leader in medical technology, enhancing the lives of patients with cardiovascular diseases. With an in-depth understanding of cardiovascular conditions and strong relationships with physicians worldwide, we develop innovative medical technologies and deliver transformative therapies. Managed by a team of highly qualified professionals, S3V Vascular Technologies brings global best practices to the Indian healthcare market. Our ambitious goals and multiple initiatives aim to make us the market leader in our focus areas. Role Description This is a full-time, on-site role for a Purchasing Executive located in Chengalpattu. The Purchasing Executive will be responsible for managing purchase orders and requisitions, overseeing procurement processes, and ensuring timely and cost-effective purchasing. The individual will liaise with suppliers, negotiate contracts, and maintain effective communication with internal departments to ensure alignment with organizational needs. Qualifications Experience in managing Purchase Orders and Purchase Requisitions Strong skills in Purchase Management and Procurement Excellent Communication skills Ability to work on-site in Chengalpattu Bachelor's degree in Business Administration, Supply Chain Management, or a related field Relevant certifications in procurement or supply chain management are a plus Proven ability to negotiate and manage supplier relationships
Role Overview: As a Purchasing Executive at S3V Vascular Technologies, located in Chengalpattu, you will be responsible for managing purchase orders and requisitions, overseeing procurement processes, and ensuring timely and cost-effective purchasing. Your role will involve liaising with suppliers, negotiating contracts, and maintaining effective communication with internal departments to ensure alignment with organizational needs. Key Responsibilities: - Manage purchase orders and purchase requisitions efficiently - Oversee procurement processes to ensure smooth operations - Liaise with suppliers and negotiate contracts - Maintain effective communication with internal departments - Ensure timely and cost-effective purchasing Qualifications: - Experience in managing purchase orders and purchase requisitions - Strong skills in purchase management and procurement - Excellent communication skills - Ability to work on-site in Chengalpattu - Bachelor's degree in Business Administration, Supply Chain Management, or a related field - Relevant certifications in procurement or supply chain management are a plus - Proven ability to negotiate and manage supplier relationships,
About the job Company Description S3V Vascular Technologies aims to be a global leader in medical technology, working towards enhancing the lives of patients afflicted with cardiovascular diseases. At S3V Vascular, we assist healthcare professionals in creating a healthier world. Our deep understanding of cardiovascular diseases and strong relationships with physicians worldwide enable us to develop innovative medical technologies and therapies that transform cardiovascular treatment. Managed by a team of highly qualified professionals, we strive to bring global best practices to the Indian healthcare market, focusing on medical device development, physician education, and patient awareness. We are setting ambitious goals to become the market leader in all our focus areas. Role Description This is a full-time on-site role for a Purchasing Executive located in oragadam, Chennai. The Purchasing Executive will be responsible for managing purchase orders, requisitions, and procurement processes. Day-to-day tasks include liaising with suppliers, reviewing and negotiating contracts, ensuring timely delivery of materials, maintaining inventory levels, and coordinating with internal teams to understand their procurement needs. Qualifications Experience with Purchase Orders, Purchase Requisitions, and Purchase Management Proficiency in Procurement processes Strong Communication skills Excellent organizational and time management skills Bachelor's degree in Business Administration, Supply Chain Management, or related field Experience in the medical technology industry is a plus Ability to work independently and collaboratively within a team Interested candidates please share your CV to hr_oragadam@s3vvascular.com only WhatsApp: 8925928455/56
Role & responsibilities Develop and execute regulatory strategies for CE marking (under EU MDR), US FDA approvals (510(k)/PMA), and CDSCO manufacturing and marketing authorizations. Ensure timely preparation, submission, and maintenance of regulatory dossiers including Technical Files, Design Dossiers, and Device Master Files. Act as primary contact with regulatory authorities (CDSCO, Notified Bodies, US FDA) and manage communications during audits, inspections, and submissions. Oversee the creation, maintenance, and submission of all regulatory documentation to ensure compliance with global regulations. Support product development teams to ensure regulatory requirements are embedded throughout the product lifecycle. Monitor changes in international regulatory requirements and provide guidance to internal teams on compliance impacts. Coordinate with cross-functional teams including Quality, R&D, Manufacturing, and Clinical Affairs to support regulatory submissions. Ensure timely renewals, variations, and post-market reporting (e.g., vigilance reporting, adverse event notifications). Lead regulatory due diligence and risk assessments for new product development and changes. Manage and mentor the RA team to build internal regulatory competency. Prepare for and support audits by regulatory authorities and notified bodies. Ensure regulatory labelling, claims, and promotional materials comply with applicable laws and regulations. Preferred candidate profile Strategic regulatory planning Expert knowledge of medical device regulations Regulatory submissions and dossier compilation Strong written and verbal communication Cross-functional leadership and collaboration Project management and attention to detail
Role & responsibilities Lead implementation and continuous improvement of ISO 13485-compliant QMS. Ensure compliance with FDA QSR (21 CFR 820), EU MDR, and other applicable regulatory requirements. Manage internal and external audits (FDA, notified bodies, ISO, etc.). Oversee document control, change control, and quality records management. Approve quality documentation, SOPs, DMRs, DHFs, and technical files. Lead root cause investigations and implement effective corrective and preventive actions. Manage nonconformances and track resolution effectiveness. Approve and audit suppliers and subcontractors. Ensure incoming materials and components meet specifications. Collaborate with production and engineering to ensure process validations (IQ/OQ/PQ) are performed and documented. Ensure in-process and final product testing meets quality standards. Prepare for and host regulatory inspections and third-party audits. Maintain inspection readiness at all times. Manage and mentor the QA team. Ensure ongoing quality and compliance training for all relevant staff. Support risk management (ISO 14971) and post-market surveillance activities. Review complaints and adverse event reports to ensure timely investigation and resolution Preferred candidate profile Leadership and team management Attention to detail and analytical thinking Excellent communication and documentation skills Strong problem-solving and decision-making abilities Project management and cross-functional collaboration
Role & Responsibilities Lead development of device coatings with and without drug-eluting capability for medical applications. Formulate and optimize polymer matrices for device coating and for controlled release from device coatings. Design and synthesize sodium-based and acid etching solutions for surface treatment and functionalization. Develop surface modifying reagents tailored for L-605, Nitinol, and other medical-grade alloys. Oversee wet chemistry lab setup including equipment specification, layout, and compliance setup. Establish lab SOPs and ensure strict adherence to EH&S and GLP standards. Plan and execute in vitro drug release studies, stability protocols, and surface characterization. Collaborate with cross-functional teams in product development, QA, regulatory affairs, and engineering. Support regulatory documentation for combination products (FDA 21 CFR Part 4, ISO 10993, etc.). Lead documentation, patent filings, and technical knowledge transfers across departments. Train and mentor junior chemists and lab personnel Preferred Candidate Profile Spin coating, dip coating, spray coating systems Electropolishing tanks, ultrasonic baths, fume hoods Surface characterization: SEM/EDS, FTIR, XPS, contact angle, profilometry Analytical methods: HPLC, UV-VIS, conductivity, titration, pH analysis Drug release and stability studies, polymer-drug compatibility screening Wet lab and synthesis protocols for acids, bases, and custom reagents
Role & responsibilities Manage production of medical-grade thermoplastic tubing using PEBAX, TPU, Nylon, and similar materials. Oversee high-precision micro-extrusion lines and ensure tight tolerance controls are maintained. Implement and maintain Statistical Process Control (SPC) practices across extrusion and braiding processes. Supervise continuous braiding operations for reinforced catheter and medical tubing. Coordinate inline extrusion-braiding integration and ensure synchronization of equipment and processes. Ensure compliance with ISO 13485, GMP, and FDA 21 CFR Part 820 standards. Lead production planning, team supervision, and performance management. Develop SOPs, batch records, and support validation protocols including IQ, OQ, PQ. Troubleshoot processing issues, material variations, and tooling concerns. Drive continuous improvement initiatives in quality, efficiency, and cost reduction. Collaborate with QA, R&D, and maintenance teams to achieve product and process excellence. Support internal and customer audits with robust documentation and corrective actions. Preferred candidate profile Thermoplastic Micro-Extrusion (PEBAX, TPU, Nylon) Continuous Medical Braiding Operations Inline Extrusion-Braiding Synchronization SPC (Statistical Process Control) Tooling and Die Design for Small-Diameter Tubing Tight Tolerance Process Control Cleanroom Manufacturing (ISO Class 7/8) ISO 13485 / FDA GMP Compliance Process Validation (IQ/OQ/PQ) Lean Manufacturing, 5S, Kaizen Team Leadership & Operator Training Audit Preparedness & Documentation Control ERP/MES System Familiarity
Job Responsibilities Manage daily production of medical-grade tubing using Ram and Fluoropolymer Thermoplastic extrusion technologies. Ensure adherence to cleanroom standards and regulatory compliance for medical device manufacturing. Develop and implement production plans to meet volume, cost, and quality objectives. Optimize process parameters for materials like PTFE, FEP, PFA, and other medical-grade fluoropolymers. Lead extrusion trials for new product development and support scale-up activities. Ensure compliance with ISO 13485, GMP, and FDA 21 CFR Part 820 requirements. Mentor and manage teams of engineers, supervisors, and operators. Drive OEE improvement, scrap reduction, and cost optimization initiatives. Implement lean manufacturing, 5S, and continuous improvement practices. Collaborate with R&D, QA, and maintenance for cross-functional process excellence. Maintain robust documentation of batch records, deviations, and CAPA. Prepare and submit production metrics, reports, and dashboards. Desired Candidate Profile Fluoropolymer Processing Expertise (PTFE, FEP, PFA, etc.) Ram Extrusion & Thermoplastic Extrusion Cleanroom Extrusion Operations (ISO Class 7 or 8) Process Validation (IQ/OQ/PQ) Extrusion Tooling & Die Design Knowledge GMP Compliance & ISO 13485 Standards Medical Tubing Specifications & Tolerances Root Cause Analysis / CAPA Implementation OEE, Yield & Scrap Reduction Techniques
About the job Company Description S3V Vascular Technologies aims to be a global leader in medical technology, working towards enhancing the lives of patients afflicted with cardiovascular diseases. At S3V Vascular, we assist healthcare professionals in creating a healthier world. Our deep understanding of cardiovascular diseases and strong relationships with physicians worldwide enable us to develop innovative medical technologies and therapies that transform cardiovascular treatment. Managed by a team of highly qualified professionals, we strive to bring global best practices to the Indian healthcare market, focusing on medical device development, physician education, and patient awareness. We are setting ambitious goals to become the market leader in all our focus areas. Role Description This is a full-time on-site role for a Purchasing Executive located in oragadam, Chennai. The Purchasing Executive will be responsible for managing purchase orders, requisitions, and procurement processes. Day-to-day tasks include liaising with suppliers, reviewing and negotiating contracts, ensuring timely delivery of materials, maintaining inventory levels, and coordinating with internal teams to understand their procurement needs. Qualifications Minimum 2+ years experience with Purchase Orders, Purchase Requisitions, and Purchase Management Proficiency in Procurement processes Strong Communication skills Excellent organizational and time management skills Bachelor's degree in Business Administration, Supply Chain Management, or related field Experience in the medical technology industry is a plus Ability to work independently and collaboratively within a team Interested candidates please share your CV to karthikeyan_m@s3vvascular.com only WhatsApp: 8925928455/56
Role & Responsibilities Production Management Lead and oversee daily production across all departments: extrusion (PTFE & thermoplastics), machining, laser cutting, and catheter assembly. Ensure productivity, yield, and OEE targets are achieved. Drive manufacturing excellence through efficient line balancing, real-time monitoring, and bottleneck elimination. Planning & Coordination Develop and implement the master production schedule based on sales forecasts and inventory requirements. Coordinate with supply chain and procurement teams to ensure material availability and capacity planning. Conduct daily/weekly production reviews and implement corrective actions as needed. People Management Lead a multidisciplinary team including production supervisors, technicians, operators, and support staff. Ensure workforce planning, training, motivation, and performance evaluation. Promote a culture of discipline, accountability, and continuous improvement. Quality & Regulatory Compliance Collaborate with Quality and Regulatory Affairs teams to ensure adherence to ISO 13485 , FDA 21 CFR Part 820 , and GMP requirements. Ensure robust in-process inspection and traceability on all lines. Lead root cause analysis and CAPA for non-conformances or deviations. Operational Excellence Drive lean manufacturing, Kaizen, 5S, and other continuous improvement initiatives. Oversee preventive maintenance planning for all plant equipment (extruders, laser systems, CNC, etc.). Implement and track production KPIs (OEE, downtime, yield, rework, etc.). Administrative & Budgetary Control Prepare and manage the plants operational budget, ensuring cost control and optimal resource utilization. Ensure installation, commissioning, IQ/OQ/PQ of equipments as per validation requirements. Ensure compliance with all labor laws, safety, and environmental regulations. Maintain documentation, shift rosters, leave schedules, and audit readiness. Preferred Candidate Profile Strategic production planning and execution Budgeting and Cost Control People leadership and conflict management Manufacturing KPIs and data-driven decision making Regulatory knowledge: ISO 13485, 21 CFR 820 Exposure to ERP/MES systems (SAP, Oracle, Plex, etc.) Lean, Six Sigma, and TPM practices Exceptional communication and team-building skills