- IQVIA (Wayne, PA)
- …true expert in both the guidance and the practice of developing strategies to engage US FDA , the EMA and other regulatory agencies on COA endpoints and the use ... regulatory component, and ensure we provide consistently high quality insights and content + Support billable projects as...development of IQVIA's responses to public consultation processes from FDA and other regulatory agencies relating to… more
- Globus Medical, Inc. (Audubon, PA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- Globus Medical, Inc. (Audubon, PA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …ZOLL the ideal place to build your career.Job SummaryDirects the activities of the Quality Assurance and Regulatory Affairs department. Ensures the quality ... (https://www.zoll.com/products/supersaturated-oxygen-therapy/therox-sso2-system) Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to… more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- **Position Summary** Provides critical support in developing global regulatory strategy, planning and execution of global investigational and marketed prescription ... activities for all assigned projects in alignment with the Global Regulatory Lead. Translates complex pertinent global requirements and provides an assessment… more
- United Therapeutics (Harrisburg, PA)
- …of biologic or pharma regulatory experience with a Bachelor's Degree in life sciences, quality , regulatory affairs or a related area of study or 10+ years of ... pulmonary arterial hypertension( **PAH)** . Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with... experience with a Master's Degree in life sciences, quality , regulatory affairs or a related area… more
- Merck (North Wales, PA)
- …+ Oversee and independently lead the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all ... documentation. + Interact independently with regulatory agencies ( FDA , EMA, etc.), including leading meetings, teleconferences, and written communications. +… more
- Charles River Laboratories (Wayne, PA)
- …responsibilities. ⦁ Assume a lead role in the development and presentation of regulatory training for Quality Assurance and operations staff. ⦁ Manage ... and Compliance projects and programs. ⦁ Participate in Corporate Quality Meetings, Regulatory Affairs and Compliance meetings,...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Jabil (West Chester, PA)
- …This person will also be responsible for the absence of significant quality systems issues and regulatory compliance actions by government agencies. ... foster vibrant and diverse communities around the globe. Are you experienced in Regulatory Compliance? Jabil is seeking a qualified Regulatory Compliance Manager… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …more than 110 countries and regions. **Summary:** Develops and implements worldwide regulatory programs for marketed products and/or those for development, and has ... interactions with regulatory authorities to expedite approvals. Participate in the development...May have responsibility for maintaining a compliant medical device quality system for R&D and informing project teams of… more