About Us
A team of regulatory experts with over 35+ years of combined experience, providing innovative solutions for medical device manufacturers worldwide.
Company & Mission
EBMCI was founded by regulatory experts with over 30 years of combined experience in the medical device industry. We recognized the need for a more efficient, data-driven approach to regulatory consulting.
Our unique combination of deep regulatory expertise and proprietary AI technology allows us to deliver faster, more accurate pathways to market for medical device manufacturers of all sizes.
With offices in the United States and Taiwan, we serve clients globally, helping them navigate the complex regulatory landscape across North America, Europe, and Asia.
Location
Taipei Office
Room 435, 4F, Building E, No. 19-13, Sanchong Rd., Nangang District, Taipei City 115601, Taiwan (R.O.C.)
Zhubei (Main) Office
229 Fuxing 2nd Rd., 2F, Suite 9, Zhubei City, Hsinchu County 30271, Taiwan (R.O.C.)
California Office (U.S. Branch)
29122 Rancho Viejo Rd., Suite 212, San Juan Capistrano, CA USA 92675
Our Mission & Values
Innovation
We continuously develop new methods and technologies to improve regulatory processes and outcomes.
Excellence
We continuously develop new methods and technologies to improve regulatory processes and outcomes.
Collaboration
We continuously develop new methods and technologies to improve regulatory processes and outcomes.
Global Coverage
We continuously develop new methods and technologies to improve regulatory processes and outcomes.
Efficiency
We continuously develop new methods and technologies to improve regulatory processes and outcomes.
Expertise
We continuously develop new methods and technologies to improve regulatory processes and outcomes.
Leadership Team
Meet the experts behind EMBCI, bringing decades of combined experience in regulatory affairs, quality management, and medical device innovation.
Jennifer Chen
CEO & Founder
Michael Rodriguez
Chief Regulatory Officer
Sarah Kim
Director of Quality Systems
Jennifer Chen
CEO & Founder
Jennifer Chen
CEO & Founder
Jennifer Chen
CEO & Founder
Our Culture
At EBRICI (Elite Biomedical Consulting, Inc.), we envision a world where innovative medical devices reach patients faster through streamlined regulatory pathways without
01
Innovation-Driven
We constantly explore new technologies and methodologies to improve regulatory processes
02
Client-Focused:
We constantly explore new technologies and methodologies to improve regulatory processes
03
Collaborative
We constantly explore new technologies and methodologies to improve regulatory processes
04
Collaborative
We constantly explore new technologies and methodologies to improve regulatory processes
Current Opportunities
Regulatory Affairs Specialist
Job Summary:
We are seeking a detail-oriented and highly organized Regulatory Affairs Specialist to join our team. This role is responsible for ensuring that our products comply with all applicable regulations and standards, both domestic and international. You will be the key liaison between our company and regulatory agencies, facilitating submissions, registrations, and compliance throughout the product lifecycle.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (Master’s or RAC certification is a plus)
- 2–5 years of experience in regulatory affairs, preferably within the pharmaceutical, medical device, or biotech industry.
- Strong knowledge of FDA, EU MDR/IVDR, ICH guidelines, and global regulatory requirements. Excellent written and verbal communication skills.
- Strong analytical, organizational, and time-management abilities. Proficient in MS Office and regulatory submission platforms (e.g., eCTD, RIMS).
Preferred Skills:
- Experience with international submissions (e.g., Canada, LATAM, Asia-Pacific).
- Familiarity with clinical trial regulatory processes.
- RAC (Regulatory Affairs Certification) or equivalent is highly desirable.
Quality Systems Engineer
Job Summary:
We are seeking a detail-oriented and highly organized Regulatory Affairs Specialist to join our team. This role is responsible for ensuring that our products comply with all applicable regulations and standards, both domestic and international. You will be the key liaison between our company and regulatory agencies, facilitating submissions, registrations, and compliance throughout the product lifecycle.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (Master’s or RAC certification is a plus)
- 2–5 years of experience in regulatory affairs, preferably within the pharmaceutical, medical device, or biotech industry.
- Strong knowledge of FDA, EU MDR/IVDR, ICH guidelines, and global regulatory requirements. Excellent written and verbal communication skills.
- Strong analytical, organizational, and time-management abilities. Proficient in MS Office and regulatory submission platforms (e.g., eCTD, RIMS).
Preferred Skills:
- Experience with international submissions (e.g., Canada, LATAM, Asia-Pacific).
- Familiarity with clinical trial regulatory processes.
- RAC (Regulatory Affairs Certification) or equivalent is highly desirable.
AI/ML Developer - Regulatory Applications
Job Summary:
We are seeking a detail-oriented and highly organized Regulatory Affairs Specialist to join our team. This role is responsible for ensuring that our products comply with all applicable regulations and standards, both domestic and international. You will be the key liaison between our company and regulatory agencies, facilitating submissions, registrations, and compliance throughout the product lifecycle.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (Master’s or RAC certification is a plus)
- 2–5 years of experience in regulatory affairs, preferably within the pharmaceutical, medical device, or biotech industry.
- Strong knowledge of FDA, EU MDR/IVDR, ICH guidelines, and global regulatory requirements. Excellent written and verbal communication skills.
- Strong analytical, organizational, and time-management abilities. Proficient in MS Office and regulatory submission platforms (e.g., eCTD, RIMS).
Preferred Skills:
- Experience with international submissions (e.g., Canada, LATAM, Asia-Pacific).
- Familiarity with clinical trial regulatory processes.
- RAC (Regulatory Affairs Certification) or equivalent is highly desirable.
Clinical Evaluation Specialist
Job Summary:
We are seeking a detail-oriented and highly organized Regulatory Affairs Specialist to join our team. This role is responsible for ensuring that our products comply with all applicable regulations and standards, both domestic and international. You will be the key liaison between our company and regulatory agencies, facilitating submissions, registrations, and compliance throughout the product lifecycle.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (Master’s or RAC certification is a plus)
- 2–5 years of experience in regulatory affairs, preferably within the pharmaceutical, medical device, or biotech industry.
- Strong knowledge of FDA, EU MDR/IVDR, ICH guidelines, and global regulatory requirements. Excellent written and verbal communication skills.
- Strong analytical, organizational, and time-management abilities. Proficient in MS Office and regulatory submission platforms (e.g., eCTD, RIMS).
Preferred Skills:
- Experience with international submissions (e.g., Canada, LATAM, Asia-Pacific).
- Familiarity with clinical trial regulatory processes.
- RAC (Regulatory Affairs Certification) or equivalent is highly desirable.
Regulatory Strategy Consultant
Job Summary:
We are seeking a detail-oriented and highly organized Regulatory Affairs Specialist to join our team. This role is responsible for ensuring that our products comply with all applicable regulations and standards, both domestic and international. You will be the key liaison between our company and regulatory agencies, facilitating submissions, registrations, and compliance throughout the product lifecycle.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (Master’s or RAC certification is a plus)
- 2–5 years of experience in regulatory affairs, preferably within the pharmaceutical, medical device, or biotech industry.
- Strong knowledge of FDA, EU MDR/IVDR, ICH guidelines, and global regulatory requirements. Excellent written and verbal communication skills.
- Strong analytical, organizational, and time-management abilities. Proficient in MS Office and regulatory submission platforms (e.g., eCTD, RIMS).
Preferred Skills:
- Experience with international submissions (e.g., Canada, LATAM, Asia-Pacific).
- Familiarity with clinical trial regulatory processes.
- RAC (Regulatory Affairs Certification) or equivalent is highly desirable.