Regulatory Affairs Specialist Medical Devices | FDA 510(k) | Quality & Compliance

Job Description

Job Description

Immediate need for a talented Regulatory Affairs Specialist – Medical Devices | FDA 510(k) | Quality & Compliance . This is a 06+months contract opportunity with long-term potential and is located in U.S(Remote). Please review the job description below and contact me ASAP if you are interested.

Job ID:26-21690

Pay Range: $35 - $38.66/hour.  Traveler benefits as per agency package. (Benefits vary by vendor and assignment.).

Key Responsibilities:

• Repare, compile, review, and coordinate regulatory submission packages for U.S. and international regulatory agencies.
• Support FDA submissions including 510(k), PMA, supplements, annual reports, registrations, and product change documentation.
• Maintain regulatory documentation, submission records, and approval databases.
• Ensure regulatory files remain accurate, complete, and audit-ready.
• Collaborate with Engineering, Quality, Manufacturing, Clinical Affairs, Marketing, and Product teams to gather required documentation.
• Assess product and design changes for regulatory impact.
• Support regulatory compliance activities, audits, inspections, and quality initiatives.
• Assist with product registrations, renewals, and ongoing lifecycle management.
• Track regulatory milestones and ensure timely submission activities.
• Stay current with FDA regulations, ISO standards, and global regulatory requirements.

Key Requirements and Technology Experience:

• Bachelor's degree in Life Sciences, Biomedical Engineering, Engineering, Chemistry, Regulatory Affairs, or a related field.
• 2–5+ years of Regulatory Affairs experience supporting medical devices.
• Experience preparing or supporting FDA regulatory submissions.
• Knowledge of 510(k), PMA, FDA regulations, Design Controls, and Quality Systems.
• Strong technical writing and documentation skills.
• Excellent organizational, analytical, and communication skills.
• Ability to manage multiple priorities while maintaining exceptional attention to detail
• FDA 21 CFR Part 820
• ISO 13485
• Design Controls
• Design History File (DHF)
• Risk Management
• Change Control
• CAPA
• Technical Documentation
• Medical Device Labeling
• Regulatory Strategy Support
• Internal or External Audits
• Global Regulatory Submissions (EU MDR, Health Canada, etc.)

Our client is a leading Biopharmaceutical Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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