Neeraj Pathak
Sr. Regulatory Affairs Specialist at SS Innovations | Gurugram, Haryana, India
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Neeraj Pathak serves as a Senior Regulatory Affairs Specialist at SS Innovations, where he leverages over 11 years of extensive experience in the field of Medical Device Regulatory Affairs. His role is pivotal in navigating the complex landscape of international regulatory submissions, ensuring compliance with stringent regulations across the US, EU, India, and other global markets. Neeraj's expertise in EU MDR remediation is particularly noteworthy, as he plays a critical role in guiding the organization through the intricacies of the European Medical Device Regulation (EU MDR) 2017/745, ensuring that all technical documentation meets the required standards for successful market entry.
At SS Innovations, Neeraj is actively involved in dossier preparation for international regulatory submissions, including the meticulous process of CDSCO registration in India. His proficiency in MD-QMS documentation and implementation of Quality Management Systems (QMS) in accordance with ISO 13485 and ISO 9001 standards has been instrumental in achieving certification audits, thereby enhancing the company’s credibility and operational efficiency in the medical device sector.
Neeraj's comprehensive skill set encompasses not only regulatory submissions but also a deep understanding of medical device import and registration processes in India. His ability to navigate the regulatory landscape with precision and foresight has positioned him as a key asset to SS Innovations, driving the successful launch of innovative medical devices while ensuring compliance with evolving regulations. Through his dedication and expertise, Neeraj continues to contribute significantly to the advancement of medical technology and patient safety on a global scale.
Sr. Regulatory Affairs Specialist at SS Innovations in January 2024 to Present
Regulatory Affairs Specialist at Medtronic in October 2021 to April 2024
System Analyst (Regulatory Affairs Medical Devices) at Tata Consultancy Services in April 2018 to October 2021
Assistant Manager Regulatory Affairs - Medical Devices at GST CORPORATION LIMITED in May 2016 to April 2018
Incharge Regulatory Affairs - Medical Devices at Advanced LifeSciences Pvt Ltd in April 2015 to April 2016
Exe. Regulatory Affairs cum Certification Auditor for ISO and CE Marking for Medical Devices at Global Accreditation System Registrar (GASR) in February 2014 to March 2015
Microbiologist at DHANUKA LABORATORIES LIMITED in May 2012 to February 2014
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EU-MDR Remediation
India/CDSCO Submission
MD-QMS Documentation
International Regulatory Submission
Internal Audits
Regulations
Medical Device Regulatory Affairs
Medical Device Import/Registration in India
Medical Device Registration
Technical Documentation as per EUMDR (EU) 2017/745
QMS Implementation as per ISO 13485
Certification Audit for ISO 13485:2016 & ISO 9001:2015
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Discover more about SS InnovationsWhat is Neeraj Pathak email address?
Email Neeraj Pathak at [email protected]. This email is the most updated Neeraj Pathak email found in 2026.
How to contact Neeraj Pathak?
To contact Neeraj Pathak send an email to [email protected]. (updated on October 29, 2024)
What company does Neeraj Pathak work for?
Neeraj Pathak works for SS Innovations
What is Neeraj Pathak's role at SS Innovations?
Neeraj Pathak is Sr. Regulatory Affairs Specialist
What is Neeraj Pathak's Phone Number?
Neeraj Pathak's phone (**) *** *** 219
What industry does Neeraj Pathak work in?
Neeraj Pathak works in the Medical Equipment Manufacturing industry.
Neeraj Pathak Email Addresses
Neeraj Pathak Phone Numbers
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