Regulatory Affairs Specialist jobs in United States
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Intellectt Inc · 1 day ago

Regulatory Affairs Specialist

positionSanta Clara, CA
timeContract
remoteOnsite
seniorityMid Level

Intellectt Inc is seeking a Regulatory Affairs Specialist to support global regulatory strategy and execution for medical device products. This role involves ensuring compliance with FDA and international regulations, partnering with various teams to manage regulatory submissions and post-market compliance activities.

Information TechnologyRecruitingStaffing Agency
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H1B Sponsor Likelynote
Hiring Manager
Mohammed Shuja
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Responsibilities

Prepare, compile, and maintain regulatory submissions including FDA 510(k), EU MDR Technical Documentation, and international registrations
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable regulatory standards
Support regulatory assessments for design, manufacturing, supplier, and labeling changes
Maintain DHF, Technical Files, and regulatory records in PLM and regulatory systems
Review product labeling, IFUs, and marketing materials for regulatory compliance and UDI requirements
Support internal and external audits, FDA inspections, and Notified Body assessments
Provide regulatory guidance during design reviews, risk management, and validation activities

Qualification

Medical device regulatory affairsFDA complianceEU MDR knowledgeISO 13485 knowledgeRisk management standardsCross-functional communicationTechnical writingDocumentation skills

Required

Bachelor's degree in Engineering, Life Sciences, or related field
Medical device regulatory affairs experience
Strong working knowledge of FDA, EU MDR, ISO 13485, and risk management standards
Excellent technical writing, documentation, and cross-functional communication skills

Company

Intellectt Inc

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Intellectt Inc.
dateFounded in 2018
location
Iselin, New Jersey, USA
people-size1001-5000 employees
web-link
https://www.intellectt.com

H1B Sponsorship

Intellectt Inc 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 (271)
2024 (255)
2023 (312)
2022 (372)
2021 (217)
2020 (134)

Funding

Current Stage
Late Stage
Company data provided by crunchbase