- 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
- 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 ... lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting and gaining...for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This… more
- Sumitomo Pharma (Harrisburg, PA)
- …other tools used within the group. + Manages the planning, tracking, compiling, quality checking and submission of required FDA Submissions (eg Establishment ... and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. + Robust understanding of FDA and… more
- System One (Malvern, PA)
- …meetings, adverse event review and reporting globally. + Perform duties as the main Regulatory Contact for FDA , Person Responsible for Regulatory Compliance, ... Job Title: Director of Regulatory and Medical Affairs Location: Malvern, PA Type:...marked surveillance monitoring and reporting activities, including those for FDA and EU MDR. + Strong organizational skills, self-directed,… 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
- 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
- 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
- Merck (North Wales, PA)
- …product life cycle. + Oversee 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. + Lead… more