- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical and Scientific Affairs group, an integral delivery unit within the Global Clinical Affairs organization, the Sr. Clinical Data Manager is accountable ... and completeness of clinical trial data in compliance with regulatory standards, SOPs, and Good Clinical Data Management Practices...+ Strong expertise in implementing and maintaining systems for global medical device trials (Class II/III or… more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Manufacturing and Controls (CMC), medical affairs and business development are critical to the success...to inform mitigation strategies in accordance with regional and/or global regulatory requirements. + Actively participate in… more
- Globus Medical, Inc. (Audubon, PA)
- …between sales and ERP Systems. **Cross-Functional Collaboration** + Collaborate with Finance, Regulatory Affairs , Supply Chain, and Marketing to align on demand ... critical role in driving the commercial success of our global medical device business. This individual will...has deep experience in sales operations within the medical device or healthcare technology industry, understands the regulatory… more
- Envista Holdings Corporation (Quakertown, PA)
- …and product direction. + Partners with Product Management, Service, Training, and Regulatory Affairs to ensure successful preparation for and execution of ... growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced… more
- Dentsply Sirona (Lancaster, PA)
- …or GED required. + Associate's or Bachelor's degree in Quality Assurance, Regulatory Affairs , or a related field is preferred. **Certifications (Preferred, ... Not Required):** + Professional certification in Quality Assurance, Regulatory Affairs , or Lean Six Sigma. **Experience:** + 1 to 5 years of experience in… more
- Stryker (Harrisburg, PA)
- …+ A basic understanding of the clinical evidence needs in the global regulatory environment for clinical investigation, clinical evaluation, post-market clinical ... studies in close collaboration with internal stakeholders from Clinical Strategy, Medical Affairs , Regulatory , HEOR, and Commercial + Ensure scientific rigor and… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …tracking, review, and collection of study-specific documents required in the site's Regulatory Binder. + Assist in tracking study activies and milestones by managing ... and maintaining study tackers and logs. + Manages device accountability for clinical studies, including tracking, shipment, and reconciliation of devices. +… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …**Experience** + Minimum of 3+ years of experience in quality assurance or regulatory affairs , preferably in the pharmaceutical, biotechnology, or medical ... are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our… more