Regulatory Affairs Specialist

Eclipse Prism Medical Devices; Navi Mumbai; On-site; INR 1,200,000 - 2,200,000; Full time

Benefits offered by this job

Health insurance

Provident Fund

Job summary

Eclipse Prism Medical Devices Pvt. Ltd. (EPMD) in Navi Mumbai seeks a Senior Regulatory Affairs Specialist to spearhead EU MDR and IMDR compliance for our medical device portfolio. You will own submissions, post-market obligations, and interactions with Notified Bodies and authorities.

Candidates should have a Biomedical Engineering background, 2–3 years in regulatory affairs with EU MDR/IMDR, and experience with Active Class IIb devices, risk management, and UDI processes.

Qualifications

• Bachelor's degree in Biomedical Engineering required.
• 2–3 years in Regulatory Affairs with EU MDR & IMDR experience.
• Master's degree in Regulatory Affairs – Medical Devices preferred.
• Experience with Active Class IIb (Class C) devices for EU MDR submissions.
• Experience leading audit clearances and resolving audit queries with Notified Bodies.
• Strong knowledge of ISO 14971 risk management and clinical evaluation.
• Experience with UDI submissions and post-market obligations.

Responsibilities

• Develop and execute regulatory strategies for EU MDR and IMDR.
• Manage CDSCO registration and manufacturing licensing for Class A–D devices.
• Prepare and maintain Technical Documentation and CERs.
• Lead EU MDR submissions for Active Class IIb devices.
• Coordinate CE marking applications and renewals.
• Ensure EUDAMED registration and UDI submissions.
• Liaise with Notified Bodies for audits and file submissions.
• Lead audit clearance efforts and resolve audit queries.
• Support regulatory inspections and post-market surveillance.
• Ensure labeling, UDI, and IFU compliance.

Skills

Regulatory strategy

Regulatory submissions

Audit management

Cross-functional collaboration

Documentation

Education

Bachelor's degree in Biomedical Engineering

Master's degree in Regulatory Affairs – Medical Devices

Job description

We're Hiring: Senior Regulatory Affairs Specialist – Medical Devices

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

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

• Develop and execute regulatory strategies for new 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)


• Lead EU MDR submissions for Active Class IIb (Class C) medical devices


• 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 audit clearances and drive timely resolution of audit queries, nonconformities, and major/minor observations


• 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

• Bachelor's Degree in Biomedical Engineering (mandatory)


• Master's degree in Regulatory Affairs – Medical Devices (preferred, added advantage)


• 2–3 years in Regulatory Affairs with hands-on EU MDR & IMDR experience. Medical devices only


• Proven experience with Active Class IIb (Class C) medical devices for EU MDR submissions


• Demonstrated experience leading audit clearances and resolving audit queries/nonconformities with Notified Bodies


• Strong working knowledge of ISO 14971 risk management and clinical evaluation


• 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

• Health insurance


• Provident Fund

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