- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... softwareEssential Functions + Performs internal quality audits and effectiveness reviews ( FDA 's QSR, ISO 13485, MDD, CMDR) Conducts supplier evaluations and audits… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …+ Build and deliver training content for IT Systems used by Quality and Regulatory . + Analyze Quality and Compliance processes, translate Quality and ... with business users, IT teams, and quality collaborators to drive adoption, ensure compliance , and improve the efficiency of digital quality tools. **A day in the… more
- Philips (New Kensington, PA)
- … and swift resolution of issues to uphold product safety and regulatory compliance , fostering transparency and cooperation in the resolution process. ... at enhancing the efficiency/effectiveness of C&R processes and maintains strict compliance with regulatory requirements governing product corrections and… more
- Teleflex (Wyomissing, PA)
- …software. Regulatory and Compliance : * Familiarity with design control processes, regulatory requirements (eg, ISO 13485 and FDA 21 CFR 820) and quality ... projects and design changes in production. * Ensure projects are developed and documented in compliance with the Quality System and with FDA and ISO standards. *… more
- Charles River Laboratories (Wayne, PA)
- …and reports and inspections of a variety of processes to assure compliance with applicable regulatory requirements, international standards, and corporate ... regulatory inspection find.ings. + Provide recommendations to Regulatory Affairs and Compliance management for improvements...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- Fujifilm (Harrisburg, PA)
- …+ Advise, counsel and report to management on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations ... in the development and structuring of new business ventures. + Keep abreast of legislative and regulatory changes that may affect HLUS and its subsidiary companies.… more
- Globus Medical, Inc. (Audubon, PA)
- …in full compliance with Globus quality system and other applicable regulatory bodies + Design and develop instruments and implants using Pro/E software + ... and market plans + Assist in the writing of regulatory applications to the FDA and other...Code, MedTech Code, and all other company policies. Ensure Compliance with applicable governmental laws, rules, and regulations, both… more
- Globus Medical, Inc. (Audubon, PA)
- …in full compliance with Globus quality system and other applicable regulatory bodies + Designing and developing instruments and implants using Creo software + ... and market plans + Assisting in the writing of regulatory applications to the FDA and other...Code, MedTech Code, and all other company policies. Ensure Compliance with applicable governmental laws, rules, and regulations, both… more
- Globus Medical, Inc. (Audubon, PA)
- …in full compliance with Globus quality system and other applicable regulatory bodies + Perform design verification and validation activities to ensure designs ... for rapid prototyping and evaluation. + Assist in writing regulatory applications to the FDA and other...compliance and product performance. + Collaborate with Quality, Regulatory , Manufacturing, and Supply Chain teams to evaluate and… more
- Merck (North Wales, PA)
- … FDA Regulations, IT Coordination, IT Operation, Pharmacovigilance, Policy Implementation, Regulatory Compliance , Regulatory Labeling, Regulatory ... 10 years of industry experience, at least 6 of those in a regulatory and/or compliance area and experience with technical systems in a regulated environment OR a… more