Head - Regulatory Affairs

Location: Chengalpattu

Company Description
S3V Vascular Technologies strives to be a global leader in medical technology, committed to improving the lives of patients with cardiovascular diseases. By leveraging strong relationships with physicians worldwide and a deep understanding of cardiovascular conditions, S3V Vascular develops innovative medical technologies that transform treatment approaches. Headquartered in India, the company incorporates global best practices to advance medical device development, physician education, and patient awareness.

S3V Vascular is driven by a team of highly qualified professionals and is dedicated to achieving ambitious goals to become a market leader in its domain.

Role Description
This is a full-time on-site position based in Chengalpattu for the role of Head - Regulatory Affairs. The position involves leading and managing the regulatory affairs function, including the development and implementation of regulatory strategies. The role requires ensuring compliance with applicable regulatory requirements, preparing and submitting regulatory documentation, and coordinating with international regulatory bodies. The individual will collaborate cross-functionally with internal teams to support the approval and maintenance of medical device products in alignment with global and local regulations.

Qualifications
Strong knowledge of Regulatory Compliance and understanding of legal frameworks

Experience with Regulatory Requirements and the ability to interpret and apply them effectively
Proficiency in developing and executing Regulatory Strategy for medical devices
Expertise in Regulatory Affairs and extensive exposure to collaborating with international regulatory bodies
Experience in preparing and submitting comprehensive Regulatory Submissions
Excellent leadership, communication, and cross-functional team collaboration skills
Master's or Bachelor's degree in  Pharmacy, Engineering, Regulatory Affairs, Life Sciences, Biomedical Engineering, or a related field
Prior experience in the medical device industry is preferred
Certification in regulatory affairs (e.g., RAC) is a plus
Develop and execute regulatory strategies for CE marking (under EU MDR), US FDA approvals (510(k)/PMA), and CDSCO manufacturing and marketing authorizations.
Act as primary contact with regulatory authorities (CDSCO, Notified Bodies, US FDA) and manage communications during audits, inspections, and submissions.

Experience with technical documentation, risk management (ISO 14971), and clinical evaluation reporting.

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