Bilal Chamas
Expert Medical Device Regulatory Affairs Consultant | 12+ Years Global Experience | PMA, 510(k), EU MDR
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 surveillance, with a proven track record in navigating complex global regulatory pathways. Bilal excels in project management, strategic planning, and ensuring robust compliance with international regulations, making him an invaluable asset to any medical technology company seeking to achieve market access and maintain regulatory integrity.
About
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 surveillance, with a proven track record in navigating complex global regulatory pathways. Bilal excels in project management, strategic planning, and ensuring robust compliance with international regulations, making him an invaluable asset to any medical technology company seeking to achieve market access and maintain regulatory integrity.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 12
- **510(k)s submitted (self-reported):** 30
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU
- **Client types:** startup, sme, large_medtech
- **Location:** United States (FL)
- **Availability:** available_now
- **Certifications:** CAPA management certification
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### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Bilal Chamas stands out as a Regulatory Affairs consultant due to his unique combination of FDA experience, medical device expertise, and technical skills. His ability to excel in global regulatory compliance, drive global regulatory success, and ensure robust compliance with international regulations makes him a valuable asset to any medical technology company. With his comprehensive skill set in medical device regulatory affairs and exceptional communication skills, Bilal offers a compelling value proposition that sets him apart from other consultants in the industry.
- **Ideal projects:** A perfect project for Bilal Chamas would be a medtech company seeking to navigate complex regulatory pathways for cardiovascular, neurology, or ophthalmic devices. With experience handling submissions for leading companies and significant contributions to EU MDR remediation projects, he excels in supporting companies with first submissions, complex devices, or international expansion projects. His expertise in technical file assessments, device technical documentation, and labeling makes him an ideal consultant for companies looking to ensure adherence to international standards and regulations. Bilal's unique combination of FDA experience, device expertise, and technical skills makes him a go-to consultant for companies seeking to achieve market access and maintain regulatory integrity.
- **Last analyzed:** Sat Dec 20 2025 01:18:01 GMT-0500 (Eastern Standard Time)
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### **Qualifications & scope**
- **Submission types:** pma, 510k-traditional
- **Specialties:** cardiovascular, neurology, ophthalmic, general-hospital
- **Device panels:** cardiovascular, neurology, ophthalmic, general-hospital
- **Regulatory pathways:** pma, 510k, post_market
---
- **Type:** independent
- **Years of experience:** 12
- **510(k)s submitted (self-reported):** 30
- **Ex-Big MedTech:** Yes
- **Regions served:** US, EU
- **Client types:** startup, sme, large_medtech
- **Location:** United States (FL)
- **Availability:** available_now
- **Certifications:** CAPA management certification
---
### **Cruxi analysis**
- **Strength summary:** 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.
- **Unique value:** Bilal Chamas stands out as a Regulatory Affairs consultant due to his unique combination of FDA experience, medical device expertise, and technical skills. His ability to excel in global regulatory compliance, drive global regulatory success, and ensure robust compliance with international regulations makes him a valuable asset to any medical technology company. With his comprehensive skill set in medical device regulatory affairs and exceptional communication skills, Bilal offers a compelling value proposition that sets him apart from other consultants in the industry.
- **Ideal projects:** A perfect project for Bilal Chamas would be a medtech company seeking to navigate complex regulatory pathways for cardiovascular, neurology, or ophthalmic devices. With experience handling submissions for leading companies and significant contributions to EU MDR remediation projects, he excels in supporting companies with first submissions, complex devices, or international expansion projects. His expertise in technical file assessments, device technical documentation, and labeling makes him an ideal consultant for companies looking to ensure adherence to international standards and regulations. Bilal's unique combination of FDA experience, device expertise, and technical skills makes him a go-to consultant for companies seeking to achieve market access and maintain regulatory integrity.
- **Last analyzed:** Sat Dec 20 2025 01:18:01 GMT-0500 (Eastern Standard Time)
---
### **Qualifications & scope**
- **Submission types:** pma, 510k-traditional
- **Specialties:** cardiovascular, neurology, ophthalmic, general-hospital
- **Device panels:** cardiovascular, neurology, ophthalmic, general-hospital
- **Regulatory pathways:** pma, 510k, post_market
---
Key Highlights
- 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
- Bilal Chamas stands out as a Regulatory Affairs consultant due to his unique combination of FDA experience, medical device expertise, and technical skills. His ability to excel in global regulatory compliance, drive global regulatory success, and ensure robust compliance with international regulations makes him a valuable asset to any medical technology company. With his comprehensive skill set in medical device regulatory affairs and exceptional communication skills, Bilal offers a compelling v
Certifications & Trust Signals
- 12 years experience
- 30 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- A perfect project for Bilal Chamas would be a medtech company seeking to navigate complex regulatory pathways for cardiovascular, neurology, or ophthalmic devices. With experience handling submissions for leading companies and significant contributions to EU MDR remediation projects, he excels in supporting companies with first submissions, complex devices, or international expansion projects. His
HQ:
United States
Languages:
English
Status:
claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), PMA
Device Types Supported:
Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
12
Num510k Submitted:
30
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
Yes
Device Panels:
cardiovascular, neurology, ophthalmic, general-hospital
Technology Types:
implantable
Accepting New Clients:
No
