Job Description

Cyient is a global engineering and technology solutions company. As a Design, Build, and Maintain partner for leading organizations worldwide, we take solution ownership across the value chain to help clients focus on their core, innovate, and stay ahead of the curve. We leverage digital technologies, advanced analytics capabilities, and our domain knowledge and technical expertise, to solve complex business problems.
With over 15,000 employees globally, we partner with clients to operate as part of their extended team in ways that best suit their organization’s culture and requirements. Our industry focus includes aerospace and defence, healthcare, telecommunications, rail transportation, semiconductor, geospatial, industrial, and energy.

Collaborate and partner with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing and Operations. Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met. With min experience of 6 + years.
POSITION RESPONSIBILITIES:
Responsibilities may include the following and other duties may be assigned:

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections
• Prepare, review, file, and support premarket documents for global registrations for assigned projects.
• Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects.
• Leads or compiles all materials required in submissions, license renewal and annual registrations
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance
• Monitors and improves tracking/control systems
• Keeps abreast of regulatory procedures and changes
• May direct interaction with regulatory agencies on defined matters
• Recommends strategies for earliest possible approvals of clinical trials applications

Skills & Experience Clinical Affairs, International Regulatory Compliance, ISO 13485 Medical Devices, Regulatory Compliance, Regulatory Processes
Cyient is an Equal Opportunity Employer.

Cyient recruits, employs, trains, compensates, and promotes regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, veteran status, and other protected status as required by applicable law. We are proud to be a diverse and inclusive company where our people can focus their whole self on solving problems that matter.