Zoot Systems is a Recent 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: SR. Manager (Medical Device)- Regulatory Affairs
Employment Type – Full time
Work Experience – 10+ Year in a similar role
Location – Dwarka (2 mints walk metro station)

Responsibilities:

EU-MDR 2017 Compliance:
- Lead the preparation and maintenance of technical documentation, including the Technical File and Design Dossier, according to EU-MDR 2017 requirements.




- Collaborate with teams to ensure completeness and accuracy of technical documentation for product registrations and conformity assessments.
- Faced the audit of the notified body

USFDA Registration:
- Manage the preparation and submission of 510(k) applications, IDEs (Investigational Device Exemptions), and premarket approval (PMA) submissions to the USFDA.
- Provide strategic guidance on regulatory pathways for product clearance and market authorization in the United States.
- Liaise with USFDA officials during inspections, audits, and communications.

ISO 13485 Quality Management:
- Develop and maintain the Quality Management System (QMS), including the preparation of the Quality Manual and Standard Operating Procedures (SOPs) in compliance with ISO 13485 requirements.
- Oversee internal audits, CAPA processes, and training programs to ensure adherence to quality standards and regulatory requirements.
-

📌 SR. Manager (Delhi)
🏢 Zoot Systems
📍 Delhi