Nordberg Medical · 1 day ago
Regulatory Affairs Specialist US
United States
Full-time
Remote
Mid Level
3+ years expNordberg Medical is a company focused on high-risk and Class III implantable medical devices. They are seeking a Regulatory Affairs Specialist US who will be responsible for preparing, reviewing, and maintaining regulatory submissions for U.S. FDA approvals while ensuring compliance with regulations throughout the product lifecycle.
ManufacturingMedicalMedical Device
No H1B
Responsibilities
Prepare, review, and submit U.S. regulatory documentation, including Investigational Device Exemptions (IDE), Premarket Approval Applications (PMA), PMA Supplements, and 510(k) submissions
Evaluate and confirm completeness and accuracy of technical and clinical documentation to support U.S. registrations
Collaborate with global RA colleagues to align submission strategies and documentation
Support discussions with CROs, external consultants, and FDA representatives, leveraging internal and external networks, in collaboration with our Global Regulatory Strategy Director and Senior Regulatory Affairs Manager
Review labeling, IFUs, and promotional materials for compliance with U.S. regulations
Ensure regulatory compliance with FDA 21 CFR 807, 812, 814 and applicable guidance for PMA and 510(k) submissions
Participate in audits and FDA inspections as a Regulatory Affairs subject matter expert
Monitor changes in U.S. regulatory requirements and assess potential impact on products and documentation
Maintain accurate regulatory records and tracking systems in compliance with ISO 13485 and internal quality system procedures
Qualification
Required
Bachelor's degree in Regulatory Affairs, Biology, Biomedical Engineering, Life Sciences, or related field
Around 3–5 years of regulatory affairs experience in the medical device industry, specifically working with degradable implants
Experience preparing, reviewing, and submitting regulatory documentation and responding to FDA inquiries
Experience using regulatory information management systems or submission tools
Experience working with CROs or external partners for regulatory submissions
Strong understanding of U.S. FDA regulatory pathways, including either PMA or 510(k) processes
Familiarity with ISO 13485, ISO 14971, and FDA Quality System Regulations (QSR)
Adaptable and growth-minded: Embraces learning opportunities and contributes to a positive, solutions-focused team culture
Detail-oriented and structured: Ensures high accuracy and compliance in documentation and submissions
Collaborative communicator: Works effectively with cross-functional teams and global colleagues
Independent and proactive: Able to organize and manage work with minimal supervision, including in a remote setting
Legally authorized to work in the United States
Company
Nordberg Medical
Nordberg Medical develops biomaterial-based products, specializing in anti-aging solutions and fully absorbable implants.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Jack Yu
Founder and CEO
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