We are Hiring: Senior Regulatory Affairs Specialist - Medical Devices

Company: Eclipse Prism Medical Devices Pvt. Ltd. (EPMD)

Location: Navi Mumbai | On-site | Full-time, Permanent

Salary Range: ₹5,00,000 – ₹6,00,000 per annum

About EPMD

We're a medical device manufacturing company with nearly 30 years of experience manufacturing and distributing high-tech surgical products. With more than 20,000 users across India, representing over 20% of the surgical workforce, we also offer custom product development and contract manufacturing for OEM partners which means genuinely diverse and complex projects for our team.

About the Role

You'll lead regulatory strategy and execution for our medical device portfolio under EU MDR (2017/745) and India's Medical Device Rules (IMDR) - owning CE marking, regulatory submissions, lifecycle compliance and post-market obligations. You'll be our main regulatory interface with Notified Bodies and EU Competent Authorities, working closely with R&D;, Quality, Manufacturing, and Commercial teams.

Key Responsibilities

- Co-develop and execute regulatory strategies for current and existing products under EU MDR & IMDR
- Manage CDSCO registration and manufacturing licensing for Class A, B, C & D medical devices
- Perform device classification, conformity assessment route selection, and regulatory gap analyses
- Prepare, review, and maintain Technical Documentation/Design Dossiers, Clinical Evaluation Reports (CER), Risk Management Files (ISO 14971), Biological Evaluation Reports (ISO 10993), and Usability Engineering Files (IEC 62366)




- Manage CE marking applications and renewals
- Ensure accurate EUDAMED registration, including UDI-DI/UDI-PI submissions and economic operator registrations
- Serve as primary liaison with Notified Bodies for audits, reviews, and technical file submissions
- Lead responses to nonconformities, major/minor observations, and regulatory inquiries
- Support EU Competent Authority inspections and investigations
- Own post-market surveillance and vigilance activities
- Ensure labeling, UDI, and IFU compliance and traceability across systems
- Monitor evolving regulatory requirements and assess impact on products and processes
- Provide regulatory guidance during design controls and product development

What We're Looking For

- 2–3 years in Regulatory Affairs with hands-on EU MDR & IMDR experience related to medical devices.
- Proven track record supporting EU MDR & IMDR certification
- Strong working knowledge of ISO 14971 risk management and clinical evaluation
- Bachelor's/Master's in Biomedical Engineering or a related discipline
- Experience with electrosurgical or surgical imaging devices is a strong advantage
- Strong analytical, documentation, and organisational skills, with the ability to manage multiple submissions in parallel
- Clear communicator, comfortable working across technical and non-technical teams

Benefits

- Health insurance
- Provident Fund

To apply: share your CV at [email protected] or apply via LinkedIn here. #RegulatoryAffairs #MedicalDevices #EUMDR #CDSCO #IMDR #Electrosurgery #Hiring #NaviMumbai #BiomedicalEngineering

📌 Regulatory Affairs Specialist (Navi Mumbai)
🏢 Eclipse Prism Medical Devices
📍 Navi Mumbai