- Merck (West Point, PA)
- …will ensure products and processes are developed in accordance with applicable regulatory , quality , company, and customer requirements. This position will lead ... + Knowledge of US and global medical device and healthcare regulations, including FDA combination products cGMP, Quality System Regulation, FDA Human… more
- Globus Medical, Inc. (Audubon, PA)
- …ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Perform design ... for rapid prototyping and evaluation. + Assist in writing regulatory applications to the FDA and other...to maintain compliance and product performance. + Collaborate with Quality , Regulatory , Manufacturing, and Supply Chain teams… more
- University of Pennsylvania (Philadelphia, PA)
- …with clinical protocol(s) as approved and in accordance with all regulatory organizations. The Director will ensure that Standard Operating Procedures (SOPs), ... Good Clinical Practices (GCP), regulatory guidelines, and all best practices are followed rigorously....review organizations, most notably the Food and Drug Administration ( FDA ). In addition to clinical trial management, the Director… more
- NTT DATA North America (Pittsburgh, PA)
- …executive visibility. Enforce compliance with PMO governance, documentation standards, and regulatory requirements (eg, FDA CSV). Drive continuous improvement by ... Experienced in delivering projects in regulated environments, ensuring compliance with FDA Computer Systems Validation (CSV) and quality standards. Led… more
- Cytel (Harrisburg, PA)
- …and associates across Cytel. + Maintain strong engagement with senior client leadership, regulatory agencies ( FDA /EMA), and key opinion leaders to support and ... junior colleagues, and driving high-impact consulting engagements. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to shape… more
- Globus Medical, Inc. (Audubon, PA)
- …ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Designing and developing ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...and market plans + Assisting in the writing of regulatory applications to the FDA and other… more
- Teva Pharmaceuticals (West Chester, PA)
- …Director, Senior Counsel, Global R&D Compliance role reports into our Global R&D, Quality , and Regulatory Legal organization. This position will provide legal ... legal support for internal investigations. + Work cross-functionally with Quality , Regulatory , IP, Compliance, Privacy, and other...+ Past experience working for a health authority (eg, FDA , EMA) preferred. + Admission to practice law in… more
- Merck (West Point, PA)
- …life while ensuring compliance with FDA , EMA, and other regulatory requirements. + Collaborate closely with Quality Assurance, Validation, Manufacturing, ... teams. + Strong knowledge of pharmaceutical manufacturing processes, equipment, and regulatory requirements ( FDA , EMA, GMP). + Expertise in reliability… more
- Globus Medical, Inc. (Audubon, PA)
- …to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Designs and develops ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...and market plans + Assists in the writing of regulatory applications to the FDA and other… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …+ Build and leverage strong relationships across departments (R&D, Supply Chain, Quality , Regulatory , Support Services) to align goals and drive decisions. ... builds, ramp-up activities, and production scaling while ensuring compliance with regulatory and quality standards (including post-market surveillance support) .… more