Head Regulatory Affairs

S3V Vascular Technologies

8 - 10 years

5 - 11 Lacs

chennai

Posted:7 hours ago| Platform:

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Skills Required

drug regulatory affairs iso standards ce marking us fda regulatory affairs pma clinical affairs hazard analysis medical devices cdsco cfr 21 cfr part 11 capa change control qms cgmp class iii medical devices

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

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