Head of Regulatory Affairs

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