- Grifols Shared Services North America, Inc (Williamsport, PA)
- … regulatory filings (IND, study reports, NDA, etc.) in cooperation with colleagues in Regulatory Affairs and other functions + Serve as program medical ... services in more than 110 countries and regions. **Position Overview:** The Medical Director will be responsible for clinical strategy relating to upcoming clinical… more
- Globus Medical, Inc. (Audubon, PA)
- …faculty members; available to meet consultant scheduling needs + Collaborate with Regulatory Affairs and Compliance; review and approve all promotional and ... At Globus Medical , we move with a sense of urgency...and reconciliation of program budgets + Partner with Professional Affairs to ensure that all appropriate consultant documentation is… more
- Penn Medicine (Philadelphia, PA)
- …continuing education and skill validation of clinical staff. Quality, Patient Safety, and Regulatory Affairs : Partnership with the Vice Chair for Quality, ... alignment with Health System Requirements. In conjunction with the Vice-Chair of Regulatory Affairs , develop programs that enhance the clinical decision-making,… more
- Edwards Lifesciences (Pittsburgh, PA)
- Patients are at the heart of everything we do. As part of our Medical Affairs team, you'll foster internal and external collaboration to generate and disseminate ... in collaboration with cross functional teams (eg, Marketing, Clinical Affairs , Regulatory Affairs , Legal) +...Assess and provide feedback on educational events funded by Medical Affairs through educational grants **What you'll… more
- General Motors (Harrisburg, PA)
- …law compliance and performance standards. You'll collaborate with Legal, Government Affairs , and regulatory experts to ensure compliance, influence future ... regulatory strategy for the AV safety case, coordinating across GPSSC, Legal, Regulatory , and Government Affairs + Develop and execute a unified roadmap for… more
- Merck (West Point, PA)
- …Data Management, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Affairs ... teams to accelerate our pipeline and deliver life-changing products for unmet medical needs world-wide. Our ability to excel depends on the integrity, knowledge,… more
- Fujifilm (Harrisburg, PA)
- …record working with Marketing, Business Development, Engineering/QA, and Regulatory Affairs . + Competitive knowledge of Medical IT and Imaging products. ... + Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all… more
- Capgemini (Pittsburgh, PA)
- …devices where applicable. *Assists with complaint investigation and documentation interfaces with Regulatory Affairs to support UL, IEC, and FDA submissions. ... Participates in internal audits conducted by internal employees and regulatory agencies. *Develop and execute supplier qualification processes, including supplier… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …ensure an enterprise approach when working with customers. Be accountable to regional Field Medical Affairs leadership to shape and execute on local medical ... The local "ecosystem approach" creates a unified focus among account management, medical , patient access and market access to engage local healthcare systems and… more
- CSL Plasma (State College, PA)
- …for completion of training and recommendation for certification by Regulatory Affairs . Functionally directs the Center Medical Staff. Provides training to ... Food and Drug Administration and in such capacity provides medical oversight in compliance with applicable Federal and State...21 of the Code of Federal Regulations and monitors medical compliance of the center. Either serves as or… more
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