L&T Technology Services · 1 day ago
Regulatory Affairs Project Manager
Bothell, WA
Full-time
Onsite
Mid, Senior Level
$63K/yr - $120K/yr
3+ years expL&T Technology Services is seeking a Regulatory Affairs Project Manager to support end-to-end CFG and export certification activities for global markets. The role involves managing CFG requests, ensuring compliance with FDA regulations, and coordinating with global regulatory teams.
ConsultingEnterprise SoftwareInformation TechnologyLife ScienceMechanical EngineeringSocial ImpactTelecommunications
Hiring Manager
Rashmi Phullera
Responsibilities
Prepare, submit, and track CFG requests via CECATS for 50+ product families
Ensure timely renewal of CFGs expiring in 2026–27 to prevent market disruption
Coordinate with FDA reviewers, respond to inquiries, and ensure “first-time-right” submissions
Perform annual establishment registration & device listing updates
Clean up outdated product codes, obsolete SKUs, and ensure complete R&L hygiene before CFG submissions
Validate supporting evidence (510(k), De Novo, PMA, exemption citations)
Coordinate with internal engineering and quality teams to confirm device status
Supply CFGs and supporting technical documents to global RA teams (India, Taiwan, Indonesia, Mexico, Costa Rica, Saudi Arabia)
Ensure country-specific wording and formatting is followed
Prepare Letters of Authorization (LOA), declarations, and distributor support documents
Maintain CFG dashboards, metrics, and submission trackers
Qualification
Required
Bachelor's degree in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs, or related field
Minimum 3–7 years hands-on experience with FDA Registration & Listing, CECATS, CFG submissions, 510(k) clearances, and global regulatory submissions
Strong understanding of FD&C Act, 21 CFR 807, 21 CFR 820, and export regulations
Experience working with global RA teams, distributors, and notified bodies
Benefits
Paid Leave
Health Insurance
Group life insurance
Disability
401(K)
Company
L&T Technology Services
L&T Technology Services is an engineering services company that offers digital, product, manufacturing, and plant engineering services.
10001+ employees
H1B Sponsorship
L&T Technology Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (787)
2024 (809)
2023 (821)
2022 (880)
2021 (872)
2020 (1441)
Funding
Current Stage
Public CompanyTotal Funding
unknown2016-09-23IPO
Leadership Team
Sanjay Barnwal
VP, Business Head Oil & Gas, Chemical & CPG Industries
Srinath Nagarur
Chief Segment Officer, Sustainability-Industrial Products
Recent News
2026-01-16
Business Standard India
2026-01-16
2026-01-16
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