Zoot Systems is a New Delhi, India based company. For years, it has been our continuous endeavours to understand Client quality-conscious discerning business needs and to successfully meet those. We specialize in the creation of high-quality I.T./Non-I.T. based HR Solutions, Recruitment, and RPO to companies of all sizes resulting in better, faster, and more meaningful results. With a focus on state-of-the-art I.T. /Non-I.T. services, Zoot Systems developed a niche and expertise in Staffing, IT Recruiting, Non-IT Recruiting, and Offshore Outsourcing services.
I have an urgent position with one of my Client; below are the Job Details kindly take a look & let me know your comfort level too.
Job Title: Regulatory Affairs (Medical Device)
Employment Type – Full time
Work Experience – 4-10 Year in a similar role
Location – Dwarka (2 mints walk metro station)
Job Overview:The individual is responsible for conducting the regulatory projects from End to End perspective, responsible for timely filing of the application, diligent review and communication with Client.



This involves expertise w.r.t Indian regulatory system and CDSCO.

Job Responsibilities:
- The minimum experience we are looking at is 3+ years
- Preparation of checklist for MD 3, MD 4, MD 7, MD 8, MD 12, MD 26, MD 14, MD 16, MD22, MD26, MD28
- Application submission for Test License, Manufacturing License, Import License, Permission to import recent medical devices
- Application filing for post-approval changes & post submission change request
- Providing regulatory guidance to the local business partner.
- Providing regulatory support for product changes/notifications, labelling, CE marking and promotional material review and approval.
- Preparation of Device Master File as per MDR 2017.
- Preparation of Site Master File as per MDR 2017.
- Preparation of documents and preparation of gap analysis as per the checklist.
- Responding to queries raised by the client and regulatory body.
- Maintaining track record for

📌 Manager – Regulatory Affairs (Delhi)
🏢 Zoot Systems
📍 Delhi