- Philips (New Kensington, PA)
- …C&R decisions, playing an important role in ensuring Sleep & Respiratory Care product quality and patient safety. **Your role:** + Will Manage the C&R team, driving ... regulatory inquiry responses, and reviews these responses to ensure compliance with C&R standards. + Leads meetings with senior...You've acquired a minimum of 8+ years' experience in FDA Regulated Post Market Surveillance (PMS), with a focus… more
- Teleflex (Wyomissing, PA)
- …production. * Ensure projects are developed and documented in compliance with the Quality System and with FDA and ISO standards. * Comply with Teleflex's ... : * Familiarity with design control processes, regulatory requirements (eg, ISO 13485 and FDA 21 CFR 820) and quality standards for medical devices. *… more
- Legrand NA (Canonsburg, PA)
- …and implementation of the organization's document management framework within the Quality Assurance department. This senior-level role ensures that all controlled ... in document control practices, drive continuous improvement initiatives, and support regulatory compliance efforts. This newly created position is due to growth and… more
- Biomat USA, Inc. (Fairless Hills, PA)
- …the daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations ... daily operational plans to achieve center performance targets related to donor throughput, quality , and productivity. + Partners with Center Manager and Quality … more
- Merck (North Wales, PA)
- …lead the preparation, submission, and follow-up of regulatory applications and ensure quality and compliance across all documentation. + Interact independently ... with global regulatory authorities to ensure successful registration and compliance . Global Immunology submission experience in IBD strongly preferred. **Primary… more
- Globus Medical, Inc. (Audubon, PA)
- …of assigned projects to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + ... + Drive design updates and documentation revisions as needed to maintain compliance and product performance. + Collaborate with Quality , Regulatory,… more
- Globus Medical, Inc. (Audubon, PA)
- …of assigned projects to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project… more
- Globus Medical, Inc. (Audubon, PA)
- …of assigned projects to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project… more
- Globus Medical, Inc. (Audubon, PA)
- …aspects of project to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project… more
- Sumitomo Pharma (Harrisburg, PA)
- …rigorous and innovative trial protocols. + Oversee clinical trial execution, ensuring quality , patient safety, and compliance with GCP standards. + Develop ... goals effectively. + Regulatory Engagement: Interface with regulatory authorities, including the FDA , EMA, and other global agencies, to secure trial approvals and… more