119 regulatory coordinator jobs at 79 companies in Devon, PA
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Regulatory Coordinator I
Allentown, Pennsylvania, United States
OnsiteFull Time
St. Luke's University Health Network: Operates a network of hospitals and medical education facilities.
1+ YOEReview, prepare, and submit clinical trial protocols to the IRB; maintain regulatory documentation; apply ICH/GCP, FDA, HIPAA and IRB policies; process IND safety reports; strong Microsoft Office skills and attention to detail.
Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft Outlook
Pennington or Hopewell or New Jersey or Pennsylvania or United States
$95k-$124k/yrOnsiteFull Time
Capital Health: Provides comprehensive healthcare services through hospitals and medical clinics.
2+ YOEBachelor of Science in Nursing required, 2 years regulatory affairs experience, NJ and PA RN credentials, knowledge of DNV/CMS standards, proficiency with Word/Excel/PowerPoint and PolicyStat, strong communication and analytic skills.
PolicyStat, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Novi Surveys, Capital Link
Cooper University Health Care: Operates a leading academic health system in South Jersey.
3+ YOEBachelor's degree required (Master's preferred),3+ years clinical research experience, managing regulatory submissions and documentation, strong communication and coordination skills.
Globus MedicalNYSE: GMED: Manufactures medical devices and robotic systems for musculoskeletal surgery.
2+ YOEPrepare and submit FDA regulatory submissions (510(k), IDE, PMA), review labeling and documentation, coordinate with cross-functional teams; 2+ years regulatory affairs experience in medical device industry; bachelor’s degree or equivalent.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Teams
Cooper University Health Care: Academic health system providing comprehensive medical and specialty care.
3+ YOERequires 3–5 years of related experience and a high school diploma; bachelor's degree in biology, research, public health, business, or healthcare administration preferred.
W. L. Gore & Associates: Develops high-performance fluoropolymer products for medical, textile, and industrial use.
1+ YOERequires 1+ year in a medical device environment, strong collaboration, communication, organization, accuracy, adaptability, and independent prioritization. Travel up to 15%; Veeva PromoMats experience preferred.
Otsuka PharmaceuticalTokyo Stock Exchange: 4578: Develops and manufactures innovative pharmaceutical and nutritional products.
7+ YOEMinimum 7 years regulatory operations experience with eCTD submissions, knowledge of FDA/EMA/Swiss Medic guidance, Documentum and publishing tools, Microsoft Office/SharePoint proficiency, staff supervision and vendor coordination.
Documentum, DocuBridge, InSight Publisher, GlobalSubmit Validate, GlobalSubmit Review, ISIToolbox, eCTD, Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft PowerPoint, Microsoft SharePoint
Temple University: Public university providing higher education, academic research, and healthcare
2+ YOEBachelor's in a related field and 2+ years research coordination experience; knowledge of clinical/translational methods, regulatory compliance, data management, scientific writing, and project coordination.
Microsoft Office Suite, SPSS, SAS, R, Stata, REDCap
Alliance Clinical Network: Operates medical research sites for Phase I-IV clinical trials.
Coordinate clinical research activities, support participant screening and consent, collect and maintain study data, and adhere to GCP/HIPAA and regulatory standards.
Electronic data capture systems, Clinical trial management software, Microsoft Excel, Microsoft Word, Microsoft PowerPoint
Penn Medicine: Academic health system providing clinical care and medical research.
3+ YOEBachelor's degree in a related field and 3+ years of oncology or health-related research coordination experience required; master's with 2+ years accepted. Requires regulatory research expertise, Excel proficiency, and strong communication skills.
Sun PharmaNSE: SUNPHARMA: Develops and manufactures generic and specialty pharmaceutical products worldwide.
1+ YOE1–3 years coordination or marketing/regulatory support experience; familiarity with MLR process and platforms; strong organization, communication, documentation, and Microsoft Office skills.
University of Pennsylvania: Research university offering higher education and healthcare services.
1+ YOEBachelor of Science and 1+ years experience, coordinate clinical trials, IRB submissions, data entry in EDC, safety reporting, biospecimen handling, and regulatory compliance.
PennCTMS, PennChart, Electronic Data Capture (EDC)
VeoliaEuronext Paris: VIE: Provides water, waste, and energy management services globally.
High school diploma, knowledge of hazardous waste industry, scheduling and regulatory compliance; OSHA HAZWOPER preferred; proficiency with computer systems.
University of Pennsylvania: Provides Ivy League higher education and conducts advanced scientific research.
1+ YOEBachelor of Science and 1–2 years experience; coordinate clinical trials, recruit/enroll subjects, abstract EHR data, manage regulatory filings, and oversee biospecimen handling.
Jefferson: Providing healthcare services and academic programs in Pennsylvania.
1+ YOEOversee clinical trial activities per GCP, coordinate protocol tasks, manage data and specimens, prepare IRB/regulatory submissions, train staff, and maintain study documentation.
Cumberland Dairy: Manufactures and packages ultra-pasteurized milk and dairy products.
2+ YOEUndergraduate degree in safety or environmental sciences, 2–5 years of safety and regulatory experience, CPR/First Aid certification, Microsoft Office proficiency, and English communication skills.
Microsoft Office Suite, Microsoft PowerPoint, Safety Data Sheets (SDS), OSHA 300 log