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Regulatory Affairs Specialist
Cyient
Develop and execute regulatory strategies for medical devices in US and EU
2d ago
Expert & Leadership (13+ years)
Full Time
Pune, Maharashtra, India
Office Full-Time
Company Size
12,733 Employees
Service Specialisms
Engineering
Digital Solutions
Consulting Services
Managed Network Services
Application Development
Sector Specialisms
Communications
Medical Devices
Life Sciences
Rail
Utilities
Telecommunications
Internet of Things (IoT)
Smart City
Role
What you would be doing
regulatory submissions
labeling review
audit support
strategy development
post‑market
udi management
- Prepare, review, and submit regulatory submissions including 510(k), PMA, Technical Documentation, and Design Dossiers.
- Collaborate with cross-functional teams including R&D, Quality, Clinical, and Manufacturing to ensure regulatory compliance throughout product lifecycle.
- Review and approve product labeling, IFUs, and promotional materials for compliance with US and EU regulations.
- Support internal and external audits, including FDA inspections and Notified Body audits, ensuring readiness and timely response to findings.
- Develop and execute regulatory strategies for Class I, II, and III medical devices in compliance with US FDA (21 CFR Part 820) and EU MDR (2017/745).
- Provide regulatory oversight for post-market surveillance, vigilance reporting, and adverse event investigations.
- Liaise with regulatory authorities including FDA and Notified Bodies, managing communications and submissions.
- Mentor junior regulatory team members and provide training on evolving regulatory requirements and best practices.
- Ensure compliance with Unique Device Identification (UDI) requirements and support EUDAMED submissions.
- Assess the regulatory impact of product and process changes and ensure proper documentation and notification.
What you bring
7+ years
medical devices
us/eu
- 07+ years of experience, specifically focused on Medical Devices in the US and EU markets
Information not given or found
Training + DevelopmentInformation not given or found
Interview process
Information not given or found
Visa SponsorshipInformation not given or found
Security clearanceInformation not given or found
Company
Overview
$879M FY2024 Revenue
Annual Financial Performance
Achieved significant revenue milestone, showcasing strong financial growth and market impact.
20+ Strategic Acquisitions
Expansion Through Acquisition
Built leadership through transformative acquisitions in plant engineering, wireless tech, and semiconductors.
- Rebranded from IT to intelligent engineering and tech solutions, shifting focus in 1991.
- Operates globally with delivery centers across North America, Europe, Asia-Pacific, and Australia.
- Provides advanced services including digital transformation, CAD/CAE, geospatial services, embedded systems, and turnkey semiconductor design.
- Specializes in heavy-industry collaborations with aerospace, energy, transportation, utilities, and semiconductor clients.
- They believe in doing the right thing, even when no one is looking.
- They embrace change and constantly look for better ways to solve problems.
- They deliver quality work and always strive for continuous improvement.
- They work as one team, across functions and geographies, to achieve success.
- They put their customers at the heart of everything they do, anticipating their needs.
- They take ownership of their actions and outcomes.
2040
Net Zero Commitment
Aims to achieve net zero carbon emissions, showcasing a long-term sustainability vision.
- Aims to reduce its carbon footprint through energy efficiency, renewable energy adoption, and sustainable operations.
- Has implemented several green initiatives, including eco-friendly office spaces and waste management programs.
- Tracks and reports its environmental impact through regular audits and public sustainability disclosures.
30% by 2025
Gender Diversity Goal
Target percentage for gender diversity in the workforce by the specified year.
- Focuses on creating an inclusive environment that promotes equal opportunities for all employees.
- Annually reports on gender diversity and inclusion metrics across various leadership and functional roles.
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