Quality Assurance Regulatory Affairs Manager

Company Description EON MEDITECH PVT. LTD., based in Gujarat, India, is dedicated to the development and manufacture of surgical implants and instruments, with a core focus on ENT (Otorhinolaryngology). The company has achieved significant recognition in Otology by being the first in India to develop titanium middle ear implants and prostheses for complex micro ear surgeries. EON Meditech offers a comprehensive portfolio that includes ENT implants, ear grommets, rhinology and laryngology products, PVA dressing packs, specialized ENT instruments, plasma surgery systems, and gelatin sponges. As one of the first and only manufacturers for several of these categories in India, the organization is committed to innovation and to transforming the ENT space through high-quality, patient-focused solutions.

ABOUT THE ROLE

We are looking for a Regulatory Manager to manage EON Meditech's regulatory submissions, product registrations, and compliance documentation across domestic and international markets. You will work closely with the technical, quality, and international sales teams to ensure our products meet all applicable regulatory requirements in every market we operate in.

WHAT YOU WILL DO

• Manage product registration and renewal applications — CDSCO, CE, USFDA, and international markets (LatAm, Middle East, Africa)

• Prepare and maintain regulatory submissions, technical files, and design dossiers

• Ensure compliance with ISO 13485, MDR, QSR, and other applicable standards

• Coordinate with international distributors and regulatory agents for local country registrations

• Review product labelling, IFUs, and promotional materials for regulatory compliance

• Track changes in regulations across key markets and advise the team accordingly

• Support audits — internal, third-party, and regulatory authority inspections

• Maintain regulatory documentation archive in an organized and audit-ready manner

WHAT WE ARE LOOKING FOR

• 5+ years of experience in regulatory affairs for medical devices

• Knowledge of CDSCO, CE marking, ISO 13485, and at least one international regulatory framework

• Excellent written English — you will write technical documents and regulatory submissions

• Detail-oriented with strong documentation and organizational habits

• Ability to work independently and manage multiple submissions simultaneously

• Experience with LatAm or Middle East regulatory processes is an added advantage.