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Bilal Chamas — PMA & 510(k) Consultant (Cardiovascular/Neurology)

Regulatory Affairs Consultant

Bilal Chamas is a highly accomplished and strategic Regulatory Affairs professional with over 12 years of dedicated experience in the medical device industry. As a critical thinker and exceptional communicator, he excels at building strong cross-functional teams and driving global regulatory success. His expertise spans the entire product lifecycle, from initial development through post-market sur...

Experience: 12+ years

Submissions: 30 510(k), 5 De Novo, 10 PMA

Expertise & Specializations

Regulatory Pathways

PMA510(k)Post-market

Device Specialties

CardiovascularNeurologyOphthalmicGeneral-hospital

Regions Served

Bilal Chamas provides regulatory consulting services to clients in:

United States (FDA)European Union (MDR/IVDR)

Credentials & Recognition

Education & Credentials

Holds a Bachelor of Science in Biochemistry from the University of California, Los Angeles, providing a strong scientific foundation for understanding complex medical devices. Further complemented by an emphasis in Pre-Pharmacy from Santa Monica College, demonstrating a deep engagement with pharmaceutical and health sciences. This robust educational background equips them with a comprehensive understanding of the scientific principles underpinning medical technology and regulatory requirements.

Member of the Regulatory Affairs Professional Society (RAPS), indicating active engagement and commitment to the regulatory affairs profession. This membership signifies a connection to a network of industry professionals and a dedication to staying abreast of regulatory best practices and developments.

Certifications

CAPA management certification
Pathwise
2014

Professional Experience

A highly experienced Regulatory Affairs professional with over 12 years in the medical device industry, demonstrating a strong career trajectory across various impactful roles. Proven ability to manage and prepare complex regulatory submissions, including PMA supplements and 510(k)s, for leading medical device companies. Expertise spans global regulatory compliance, with significant contributions to EU MDR remediation projects, technical file assessments, and international registrations. Adept at leading cross-functional teams and ensuring product compliance throughout the lifecycle, making them a valuable asset for navigating intricate regulatory landscapes.

Former Big MedTech RA Leader
Enterprise experience

Executive Summary

Professional Overview

Bilal Chamas is a highly accomplished and strategic Regulatory Affairs professional with over 12 years of dedicated experience in the medical device industry. As a critical thinker and exceptional communicator, he excels at building strong cross-functional teams and driving global regulatory success...

Core Specializations

Regulatory Pathways

PMA510(k)Post-market

Device Specialties

CardiovascularNeurologyOphthalmicGeneral-hospital

Services Offered

Regulatory Pathway Assessment
Strategic assessment to determine the appropriate FDA regulatory pathway (510(k), De Novo, PMA) for your medical device.
510(k) Authoring & Submission
Complete 510(k) submission preparation, documentation authoring, and FDA submission management.
De Novo & PMA Strategy
Strategic planning and support for De Novo and PMA pathways, including clinical trial design and FDA meeting preparation.
Post-Market Support
Post-market surveillance, adverse event reporting, and ongoing regulatory compliance support.

Cruxi Independent Snapshot

Best suited for

  • • MedTech companies seeking expert regulatory guidance

Experience signals

  • Regions: US, EU
  • Background: 12+ years of regulatory experience.

Cruxi view

A seasoned Regulatory Affairs consultant with an impressive 12 years of experience, Bilal Chamas specializes in medical device regulatory affairs, boasting expertise in PMA supplements, 510(k)s, and EU MDR remediation. With a proven track record in managing and preparing complex regulatory submissions, he excels in global regulatory compliance and is adept at leading cross-functional teams. His comprehensive skill set in medical device regulatory affairs, including proficiency in PMA supplements and EU MDR remediation, makes him a valuable asset for navigating intricate regulatory landscapes. As a certified CAPA management professional, Bilal ensures robust compliance with international regulations, making him an invaluable asset to any medical technology company seeking to achieve market access and maintain regulatory integrity. His exceptional communication skills and ability to drive global regulatory success make him a standout consultant in the industry.

This analysis is generated by Cruxi AI using public information and may not capture the full scope of the consultant's experience.

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