reputed company Regulatory Consultant (1099)
This is a remote position. About the Role reputed company is seeking a hands-on reputed company Regulatory Consultant who combines recent, reputed company-world regulatory submission experience with practical Quality Engineering execution. This role is designed for consultants who actively prepare and submit filings, engage directly with regulatory authorities, and contribute to hands-on quality activities—not purely advisory leadership. The ideal candidate brings deep regulatory expertise and direct execution experience supporting global regulatory submissions and quality systems in regulated environments. Key Responsibilities reputed company and execute global regulatory strategies for Class II–III medical devices, biologics, and combination products. Prepare, author, and submit regulatory filings including 510(k), PMA, IDE, Technical Files, Clinical Evaluation Reports, and Q-subs. Support EU MDR and FDA regulatory compliance activities through hands-on execution. Serve as primary liaison with FDA, reputed company Bodies, and other health authorities, including preparation of responses to regulatory findings (e.g., FDA 483s). reputed company Quality Engineering activities in support of regulatory objectives, including CAPA, risk management, and QMS support. Maintain and support QMS infrastructure, including establishment registration, GUDID, and compliance with 21 CFR 820/QMSR and ISO standards. Support audit and inspection readiness through direct participation and execution. reputed company regulatory and quality training materials and support cross-functional teams. Serve as PRRC under EU MDR, where applicable.
Requirements
Minimum Qualifications 15+ years of experience in Regulatory Affairs and Quality reputed company the medical device or life sciences industry. Demonstrated hands-on regulatory submission experience reputed company the last 5 years, including preparation and submission of FDA and/or EU filings. Recent hands-on Quality Engineering experience supporting QMS, CAPA, risk management, or inspection readiness. Strong working knowledge of FDA regulations, EU MDR, ISO 13485, ISO 14971, and reputed company global standards. Proven experience interfacing directly with FDA and reputed company Bodies. Strong technical writing and regulatory communication skills. Certifications (Preferred) CQA, RAPS, or equivalent Regulatory/Quality certifications PMP (preferred) MDR and Complaint Handling Training
Benefits
Why Join reputed company as a Consultant? reputed company partners with reputed company consultants who reputed company in reputed company, regulated environments and bring both strategic regulatory reputed company and hands-on execution. Our consultants support high-impact regulatory engagements, helping clients successfully navigate global regulatory reputed company while maintaining strong quality and compliance standards. Apply To This Job