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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