Job Title: Regulatory Affairs Contractor
Engagement Type: Contract (Hourly / Time & Materials)
Duration: 6-12 Months
Workload: 20-40 hours/week (Flexible)
Reporting To: VP - Regulatory Affairs

Job Summary

We are seeking an experienced Regulatory Affairs Contractor to support end-to-end FDA 510(k) submissions and global regulatory documentation for medical devices. The role involves preparing regulatory submissions, reviewing technical files, ensuring compliance with FDA, EU MDR, and Health Canada requirements, and supporting global regulatory strategy across cross-functional teams.

Key Responsibilities

FDA 510(k) Submissions
- Review technical documentation (design controls, V&V;, risk, labeling, clinical evidence, software)
- Perform regulatory gap assessments (21 CFR 807 & 820)
- Prepare FDA 510(k) submissions in eSTAR format
- Manage submission lifecycle (RTA readiness, FDA interactions, deficiency responses)

EU MDR Compliance
- Conduct Class IIa readiness and gap assessments
- Review technical documentation (Annex II & III)




- Support CE Mark submissions and Notified Body interactions

Health Canada Submissions
- Define regulatory pathway and classification
- Prepare Medical Device License (MDL) submissions
- Support responses to regulatory queries

Global Regulatory Strategy
- Develop global regulatory documentation strategy and reuse models
- Identify gaps, risks, and compliance requirements
- Support regulatory roadmap and submission planning

Cross-functional Support
- Work closely with R&D;, Quality, Clinical, and Project Management teams
- Ensure regulatory alignment across product lifecycle

Required Qualifications
- Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or related field
- 5-10+ years of medical device regulatory experience
- Solid hands-on experience with FDA 510(k) submissions (end-to-end)
- Knowledge of FDA 21 CFR 807 & 820 and eSTAR system
- Experience with EU MDR (2017/745), Class IIa technical documentation
- Experi

📌 Regulatory Affairs Contractor (India)
🏢 Real Soft
📍 India