DermCare Management: Dermatology practice management group providing operational and administrative support.
High school diploma or GED and previous clinical trial experience required; knowledge of GCP, FDA regulations, medical terminology, clinical processes, and research databases. Phlebotomy experience may be required.
Good Clinical Practice (GCP), FDA, HIPAA, OSHA, Standard Operating Procedures (SOPs)
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
1+ YOEBachelor's degree,1+ years manufacturing/regulatory experience,knowledge of GMP/ISO/FDA risk management,MPI/NPI support,CAPA and audit experience.
LupinNational Stock Exchange of India: LUPIN: Develops and manufactures generic and branded pharmaceutical products globally.
1+ YOEBachelor’s degree in chemistry/biology/microbiology/pharmacy field; 1-3 years in FDA-regulated QA; knowledge of cGMP; document control; strong English communication.
ChewyNYSE: CHWY: Online retailer of pet food, supplies, and veterinary services.
10+ YOE10+ years R&D/product development experience, scientific leadership, knowledge of USDA/FDA/AAFCO, product commercialization, strong stakeholder influence, and advanced degree preferred.
ADMA BiologicsNASDAQ: ADMA: Develops and manufactures plasma-derived human immune globulin products.
2+ YOEPharmD, RPh, RN, PhD, or similar background; 2–4 years of pharmaceutical industry experience in drug information, strong writing and organizational skills, and compliance with FDA regulations.
CSLASX: CSL: Global biotechnology producing plasma-derived and recombinant therapies.
High school diploma or equivalent required; 12 months of medical or healthcare experience preferred. Must follow SOP, FDA, HSE, and OSHA procedures and perform venipuncture and plasma collection.
Personal Digital Assistant (PDA), electronic donor information management system, Standard Operating Procedures (SOPs), Food and Drug Administration (FDA), Occupational Safety and Health Administration (OSHA)
Aveva Drug Delivery Systems: Develops and manufactures transdermal patches and oral films.
1+ YOEHigh school or equivalent, 1+ years set-up/mechanic experience in manufacturing, cGMP/FDA knowledge, mechanical aptitude, troubleshooting and packaging equipment operation skills, English proficiency.
CenExel: Conducts clinical trials through a network of research sites.
2+ YOEDoctor of Pharmacy required; licensed pharmacist in Maryland; 2+ years related experience; knowledge of FDA/GCP/ICH; ability to prepare/dispense investigational drugs and maintain IP systems.
Flourish Research: Conducts multi-site clinical trials and patient research studies.
2+ YOEMinimum two years clinical research experience, clinical skills (phlebotomy, ECG, injections) preferred; familiarity with e-source, ICH/FDA/GCP, strong organization and communication, Microsoft Office proficiency.
SHL Medical: Design and manufacture advanced drug delivery systems and autoinjectors.
5+ YOE5+ years manufacturing experience in FDA-regulated environment, high school diploma (associate preferred), knowledge of cGMP and OSHA, ability to lift 45lb, supervisory experience, MS Office and SAP proficiency.
NestléSIX Swiss Exchange: NESN: Produces and sells a wide range of food and beverages.
Deliver and adapt production training, maintain GMP and compliance with FDA/USDA, complete trainer and coaching certifications, strong communication and basic technical skills, 1–2 years' proficiency with Microsoft Office.
Microsoft Excel, Microsoft Word, Microsoft Outlook
CenExel: Operates a nationwide network of clinical research sites.
2+ YOEDoctor of Pharmacy, licensed as a registered pharmacist in Maryland, minimum 2 years related experience, knowledge of FDA/GCP/ICH, investigational drug dispensing and IP management, SOP development, and staff training.
Specialist II Post Market Surveillance (United States)
Miami Lakes, Florida, United States
OnsiteFull Time
Cordis: Developer of interventional cardiovascular and endovascular medical devices.
3+ YOE3+ years relevant experience with a Bachelor's degree (or equivalent) required; investigates and processes product complaints, evaluates regulatory reporting (MDR/MDV), supports audits, and ensures compliance with FDA and EU MDD.
CSLASX: CSL: Global biotechnology developing and manufacturing protein-based therapies and vaccines.
High school diploma or equivalent required; 12 months of medical or healthcare environment experience preferred. Must perform venipuncture, plasma collection, equipment troubleshooting, and follow SOP, FDA, HSE, and OSHA requirements.
Personal Digital Assistant (PDA), electronic donor information management system
International Medical Industries: Manufactures tamper-evident caps and sterile medical compounding devices.
7+ YOEBachelor's in engineering, 7+ years experience (min 5 years in FDA/GMP), statistical analysis (DOE, SPC), CAD and Minitab proficiency, project management, strong communication and cross-functional collaboration skills.
CAD, Minitab, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, ERP, Smartsheet
Senior Regulatory Affairs Specialist-Hybrid Fort Lauderdale, FL
Fort Lauderdale, Florida, United States
HybridFull Time
Trividia Health: Manufacturer of blood glucose monitoring systems and diabetes supplies.
5+ YOEB.S. in life sciences/engineering plus 5+ years regulatory affairs experience in medical device/IVD; post-market compliance, change management, and FDA submission exposure; strong technical writing and communication.
Microsoft Office, electronic document management systems
BrightSpring Health Services: Providing home and community-based health and pharmacy services.
Bachelor's in Pharmacy (PharmD preferred), current state pharmacist license, knowledge of drug therapy and regulatory standards (CMS, DEA, FDA), proficiency with electronic medical records and pharmacy systems, strong clinical judgment and communication.