- Globus Medical, Inc. (Audubon, PA)
- …product managers to develop forecasts and market plans . Assists in the writing of regulatory applications to the FDA and other regulatory bodies . Partners ... team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering… more
- Globus Medical, Inc. (Audubon, PA)
- …product managers to develop forecasts and market plans + Assists in the writing of regulatory applications to the FDA and other regulatory bodies + Partners ... team is inspired by the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture of exceptional response by partnering… 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 ... America Corporation, we're redefining innovation across the industries we touch-from healthcare and photography to semiconductors and data storage. With roots in… more
- Philips (New Kensington, PA)
- …and inspections related to C&R requests, aids in strategy development, oversee regulatory inquiry responses, and reviews these responses to ensure compliance with ... the process, including complaint handling, engineering change orders, kit suppliers, regulatory submissions, and field deployments. + Provides pertinent feedback and… more
- Globus Medical, Inc. (Audubon, PA)
- …product managers to develop forecasts and market plans + Assisting in the writing of regulatory applications to the FDA and other regulatory bodies + ... the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture...product development + Creating and maintaining project plans and FDA complaint Design history Files (DHF) for each project… more
- Globus Medical, Inc. (Audubon, PA)
- …shops and external vendors for rapid prototyping and evaluation. + Assist in writing regulatory applications to the FDA and other regulatory bodies. + ... the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture...software (CREO). + Create and maintain project plans and FDA -compliant Design History Files (DHF) for each project. +… more
- Globus Medical, Inc. (Audubon, PA)
- …product managers to develop forecasts and market plans + Assist in the writing of regulatory applications to the FDA and other regulatory bodies. + ... the needs of these patients, and the surgeons and healthcare providers who treat them. We embrace a culture...product development + Create and maintain project plans and FDA complaint Design history Files (DHF) for each project… more
- Sanofi Group (Swiftwater, PA)
- …industry. + Key technical competencies and soft skills: + Sound knowledge and understanding of regulatory (including FDA 21 CFR Part 11, EU Annex 11) and GAMP ... CSV Engineer **Location:** Swiftwater, PA **About the Job** We deliver 4.3 billion healthcare solutions to people every year, thanks to the flawless planning and… more
- Fujifilm (Harrisburg, PA)
- …Manager. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... by the Area Service Manager. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate...a must along with ability to maintain paperwork to FDA and company required standards. + Excellent analytical and… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... customer sites as directed by service management. **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to innovate for a healthier… more