Endimension Technology Private Limited is hiring a Regulatory Affairs Specialist for its on-site team in Navi Mumbai, Maharashtra. The company is a HealthTech organisation founded by IIT alumni that develops AI-powered Software as a Medical Device (SaMD) solutions.
This opportunity is suitable for candidates with 1–2 years of experience in medical device regulatory affairs and knowledge of regulatory documentation, quality management systems, and medical device approvals across domestic and international markets.
Job Details
| Particulars | Details |
|---|---|
| Company | Endimension Technology Private Limited |
| Job Title | Regulatory Affairs Specialist |
| Job Location | Navi Mumbai, Maharashtra, India |
| Work Mode | On-site |
| Employment Type | Full-time |
| Experience | 1–2 years |
| Industry | HealthTech, Medical Devices, SaMD |
| Hiring Contact | Malvi Verma, HR Manager |
| malviverma@endimension.com |
Positions Available
Regulatory Affairs Specialist
The selected candidate will support regulatory submissions, technical documentation, quality management system activities, and compliance requirements for software-based medical devices.
Key Responsibilities
- Prepare and maintain regulatory dossiers and technical documentation for Software as a Medical Device (SaMD).
- Support medical device registrations, product approvals, and regulatory submissions.
- Manage ISO 13485 Quality Management System (QMS) documentation and audit readiness.
- Develop and maintain Instructions for Use (IFUs), product labelling, clinical evaluation, and risk management documentation.
- Support post-market surveillance and regulatory compliance activities.
Eligibility and Qualifications
Candidates applying for the Regulatory Affairs Specialist position should meet the following requirements:
- A degree in Life Sciences, Pharmacy, Biomedical Engineering, or a relevant discipline.
- 1–2 years of experience in medical device regulatory affairs.
- Knowledge of the Indian Medical Device Rules, 2017, and EU MDR 2017/745.
- Experience in medical devices or digital healthcare is preferred.
- Knowledge of US FDA 510(k) submissions or CE marking is an added advantage.
Required Skills
- Regulatory documentation and dossier preparation.
- Medical device registration and regulatory submission support.
- ISO 13485 QMS documentation and audit readiness.
- Understanding of clinical evaluation and risk management documentation.
- Post-market surveillance and regulatory compliance.
- Strong analytical, documentation, and communication skills.
Application Details
Interested candidates can apply for the Regulatory Affairs Specialist position at Endimension Technology Private Limited in Navi Mumbai.
Hiring Contact: Malvi Verma, HR Manager
Email: malviverma@endimension.com
