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,