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Director, Quality & Regulatory- Mergers & Acquisitions (M&A)
Colorado Springs or Nashville or Bothell or Gainesville or San Diego or Plymouth or Cambridge
$162k-$258k/yr HybridFull Time
15+ YOE15+ years in FDA-regulated medical device environments, leadership in quality/regulatory and M&A, Bachelor's required (Master's/MBA preferred), knowledge of FDA/ISO/EU MDR, QMS and KPI-driven governance.
QMS, FDA, ISO 13485, ISO 14971, EU MDR, TSLA, KPI
1mo
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Sr. Cost Optimization Project Manager
Gainesville, Florida, United States
OnsiteFull Time
6+ YOEBachelor's in engineering/operations/supply chain required; 6+ years in medical device or regulated manufacturing; 2+ years leading cross-functional programs; proven cost reduction, value engineering, and regulatory (ISO/FDA/Design Controls) experience.
Lean, Six Sigma, Value Engineering, Design-to-Cost, Design Controls, Quality Management System (QMS), ISO, FDA
1mo
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Sr. Cost Optimization Project Manager
Gainesville, Florida, United States
OnsiteFull Time
6+ YOEBachelor's in engineering/operations/supply chain, 6+ years in medical device or regulated manufacturing, 2+ years leading cross-functional programs, experience driving cost-out/value engineering, knowledge of Design Controls, QMS, ISO, and FDA requirements.
Design Controls, Quality Management System (QMS), Lean, Six Sigma, ISO standards, FDA regulations, BOM
3mo
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New Product Development Engineer
Gainesville, Florida, United States
OnsiteFull Time
Bachelor's degree in engineering; experience in regulated manufacturing; DFM/DFA design input; product transfer to manufacturing; knowledge of FDA, ISO; cross-functional collaboration.
CAD viewers, ERP/MRP, document control systems
1w
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Plasma Center Nurse – LPN
Gainesville, Florida, United States
$24-$33/hr OnsiteFull Time
2+ YOELPN/LVN licensure in state of assignment, current CPR/AED, basic IV therapy, FDA Medical Support Specialist training, and minimum 2 years clinical experience.
1w
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Plasma Processor
Gainesville, Florida, United States
$15-$20/hr OnsiteFull Time
High school diploma required, attention to detail, follow cGMP/SOP/FDA/OSHA guidelines, work in fast-paced regulated environment, flexible hours including evenings/weekends/holidays.
3w
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Phlebotomist
Ocala, Florida, United States
OnsitePart Time
0.5+ YOEPerforms venipuncture and pheresis procedures following SOPs and FDA guidelines; monitors donors and equipment, documents incidents, and maintains donor records. Requires high school diploma and prior phlebotomy or medical environment experience.
Personal Digital Assistant (PDA)
1w
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Medical Support Specialist - EMT
Gainesville, Florida, United States
$23-$31/hr OnsiteFull Time
2+ YOEState EMT-Paramedic licensure, CPR/AED and basic IV therapy per state, FDA BioLife MSS training, 2+ years clinical experience, ability to evaluate donor eligibility and manage adverse events.
1mo
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Clinical Research Coord II - Pulmonary
Gainesville, Florida, United States
$53k-$70k/yr OnsiteFull Time
2+ YOEBachelor's degree plus 2 years relevant experience (or equivalent). Coordinate clinical trials, manage regulatory filings, maintain study databases, ensure GCP/ICH/FDA compliance, and communicate with sponsors and clinical teams.
OnCore, REDCap, EPIC, Medidata, Electronic Medical Records (EMR)
3w
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Laboratory Validation Coordinator
Gainesville, Florida, United States
$70k-$84k/yr OnsiteFull Time
1+ YOEBachelor's in clinical/chemical/biological science, 1+ year laboratory experience, knowledge of FDA/cGMP/AABB/FACT-JACIE and GDP, experience with method validation/qualification for cellular therapy, ability to work variable shifts.