LivaNovaNASDAQ: LIVN: Manufactures medical devices for cardiac and neurological therapies.
8+ YOEBachelor's degree in engineering; 8+ years quality/manufacturing engineering experience; regulated FDA medical device environment preferred; strong quality and project management skills.
Quality Management System (QMS), ISO 13485, MDSAP, FDA regulations
Octapharma: Manufacturer of human protein therapies from plasma.
Leadership role overseeing donation center operations, regulatory compliance (FDA/OSHA/CLIA/GMP), quality and safety programs, staff management, training, and achievement of production and financial targets; bachelor’s preferred.
Cellipont Bioservices: Contract development and manufacturing organization for cell therapies.
4+ YOEB.S. in a life science, 4+ years biotech/pharma/cell therapy experience, hands-on mammalian cell culture and analytical method qualification/validation experience, flow cytometry/ELISA/PCR familiarity, knowledge of cGMP/ICH/FDA.
flow cytometry, ELISA, PCR, ALCOA+, GMP, GDP, ICH, FDA
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
0+ YOEBachelor's in engineering or technical field (or equivalent), 0–2+ years engineering experience, knowledge of FDA/GMP/ISO standards, experience with quality tools, statistical/data analysis, Six Sigma/Lean experience preferred, strong communication and project skills.
FDA, GMP, ISO 13485, ISO 14971, Six Sigma, Lean Manufacturing, QMS, EMS
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
0+ YOEBachelor's in engineering or technical field (or equivalent), 0-2+ years engineering experience, knowledge of FDA/GMP/ISO 13485 & 14971, use of quality tools, Six Sigma/Lean experience preferred, strong communication and statistical/data analysis skills.
FDA, GMP, ISO 13485, ISO 14971, Six Sigma, Lean Manufacturing, QMS, EMS, CAPA
The University of Texas MD Anderson Cancer Center: Comprehensive cancer treatment, medical research, and education center.
8+ YOE2+ MgmtBachelor's in life sciences/pharmacy/medicine required, Master’s preferred; 8+ years regulatory affairs experience with FDA submissions, 2+ years lead project management, RAC preferred, strong FDA/ICH/GCP knowledge.
Regulatory Compliance Specialist - Transplant Center
Houston, Texas, United States
OnsiteFull Time
Houston Methodist: A non-profit health system providing comprehensive hospital and specialty medical services.
2+ YOEBachelor's degree, 2 years clinical research or regulatory compliance experience in academic/FDA-regulated settings; knowledge of IRB/FDA/GCP, strong communication, data entry, and process improvement skills; Excel/Word/PowerPoint proficiency.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint
Air LiquideEuronext Paris: AI: Supplies industrial and medical gases, technologies, and related services.
3+ YOE2+ MgmtOversee plant operations, manage production and staff, ensure regulatory compliance (FDA/DOT/OSHA/EPA), and support inventory, maintenance, and quality programs.
DM Clinical Research: A privately owned research management organization delivering clinical trial services.
8+ YOE5+ Mgmt8+ years clinical research experience; 5+ years managing multiple trials and teams; strong knowledge of FDA regulations, ICH-GCP, and site operations.
Inception Fertility: Operates a network of clinics providing comprehensive fertility services.
1+ YOECMA certification or LVN or RN license valid in Texas, 1–2 years medical experience, knowledge of OSHA/FDA/HIPAA, skilled charting, and strong communication.
Bayport Laboratories: Contract manufacturer of cosmetics, skincare, and hair care products.
5+ YOEBachelor's in Chemical Engineering, over 5 years process engineering experience in cosmetics, proficiency with MS Office, knowledge of GMP/FDA, strong analytical and communication skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
DM Clinical Research: Operates an integrated network of clinical trial research sites.
Current clinical licensure (NP or PA), clinical research and nursing experience, knowledge of FDA/GCP/ICH, ability to perform exams, EKGs, phlebotomy, and document study procedures.
Millar: Manufacturer of catheter-based pressure sensing and telemetry systems.
1+ YOEBachelor's in engineering, 1+ years medical device experience, project management skills, SolidWorks and Microsoft Office proficiency, knowledge of cGMP/FDA/ISO, ability to travel up to 10%.
3+ YOEBachelor's or equivalent preferred, typically 3+ years related experience, supervisory experience preferred, knowledge of FDA/OSHA/CLIA/cGMP regulations, budgeting and staffing, leadership and training skills.
Rice University: Private research university providing undergraduate and graduate degree programs.
Doctorate in chemistry/biochemistry/biomedical engineering, experience in dye synthesis or photoacoustic imaging, ability to design experiments, analyze data, write papers, and support IND/FDA regulatory steps.
spectroscopy, photoacoustic imaging system, Investigational New Drug (IND), Food and Drug Administration (FDA)