Regulatory Affairs Specialist

Our team is growing at Endimension! 🚀
We are looking for a Regulatory Affairs Specialist to join our growing team in Navi Mumbai!
Endimension is a HealthTech company founded by IIT alumni, developing AI-powered Software as a Medical Device (SaMD) solutions to improve healthcare and patient care.
If you have 1–2 years of experience in medical device regulatory affairs, with an interest in regulatory documentation, quality management systems and medical device approvals across domestic and international markets, we’d love to hear from you!
Key Responsibilities:
- Prepare and maintain regulatory dossiers and technical documentation for SaMD.
- Support medical device registrations, product approvals and regulatory submissions.
- Manage ISO 13485 Quality Management System (QMS) documentation and audit readiness.
- Develop and maintain IFUs, labelling, clinical evaluation and risk management documentation.
- Support post-market surveillance and regulatory compliance activities.
What We’re Looking For:
- A degree in Life Sciences, Pharmacy, Biomedical Engineering or a relevant discipline.
- Knowledge of Indian Medical Device Rules, 2017, and EU MDR 2017/745.
- Strong documentation, analytical and communication skills.
- Experience in medical devices or digital healthcare is preferred; knowledge of US FDA 510(k) or CE marking is an added advantage.
📍 Location: Navi Mumbai (On-site)
💼 Experience: 1–2 years
Join us to work on meaningful healthcare challenges, contribute to the development of AI-driven medical technologies, and grow with a collaborative & innovative team.
Interested? Apply now and be part of our journey!
#Hiring #RegulatoryAffairs #MedicalDevices #SaMD #HealthTech #MedTech #EndimensionTechnology

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