- Philips (Reedsville, PA)
- …medical device regulations. + Work closely with R&D, manufacturing, quality, and regulatory teams to align on requirements and solutions. Lead technical discussions ... Qualify new components and ensure all parts meet Philips standards and comply with FDA , ISO 13485, and IEC 60601 requirements. **You're the right fit if:** + You've… more
- Vitalief (Philadelphia, PA)
- …study visits, maintain databases, and ensure accurate data collection/entry. + Manage regulatory binders, IRB submissions, and compliance with FDA , IRB, and ... GCP guidelines. + Monitor safety events, prepare reports, and support sponsor/audit visits. + Maintain study records (OnCore, Epic, ClinicalTrials.gov) and oversee research billing reviews. + Assess and report study patients appropriately for… more