- Merck (Harrisburg, PA)
- …medical devices and combination products globally. * Experience in design controls, device risk management , medical device , complex ... design control, risk analysis and change control management for medical device or...Ethical Compliance, GMP Documentation, ISO 13485 Medical Devices , ISO 14971 Risk Management ,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …prevention and control). + Minimum of 2 years Medical Safety, risk management Vigilance or other Medical Device Experience ( Medical Device ... Medical Safety ( Medical Device preferred to Pharma) or Risk Management ( Medical Device ) experience. + Extended periods of time doing… more
- Fujifilm (Harrisburg, PA)
- …to be an integral part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas Corporation and FUJIFILM SonoSite, ... The Senior Counsel, reporting to the Division General Counsel, Medical Devices , will be an experienced commercial...working independently and collaboratively on legal issues affecting the Medical Device businesses to minimize risks of… more
- Merck (West Point, PA)
- …Combination Products, Device Development, Drug Delivery, Injection Moldings, Management Process, Manufacturing Compliance, Medical Devices , Product ... partners in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a...in design controls, device transfer, control strategies, device risk management , and design… more
- WellSpan Health (Gettysburg, PA)
- …days **General Summary** Performs a variety of functions related to implanted cardiac device management in the ambulatory and/or inpatient care settings. These ... + Documents information and reports in Cardiac Implanted Electronic Device (CIED) software and Electronic Medical Record...practices. + Works closely with other members of the device management team to ensure competency and… more
- Jabil (West Chester, PA)
- …and foster vibrant and diverse communities around the globe. Are you experienced in Medical Device Regulatory Compliance? Jabil is seeking a qualified Medical ... work in our West Chester, PA site. As the Medical Device Regulatory Compliance Lead , you...expert for Regulatory Compliance programs. + Internal Audit Program management and execution. + Establish and execute an effective… more
- Merck (West Point, PA)
- …that manufacture, assemble, and test complex injection molded Device Components, Device Constituents, and Medical Devices used to deliver Pharmaceutical, ... goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , Product Release, Change Control).… more
- Philips (New Kensington, PA)
- …+ Navigate matrixed organizations and multi-site structures, ensuring program cohesion, risk management , and issue resolution through robust tracking and ... Minimum of 8+ years of professional experience in product/solution development within FDA-regulated medical device or technology sectors. + Minimum of 8+ years… more
- UPMC (Pittsburgh, PA)
- UPMC Corporate Legal is seeking a Senior Risk Management Specialist to join the team in Oakland, PA. This hybrid role offers a mix of onsite and remote work. ... Reporting to the Senior Manager, Corporate Risk Management , the role involves systematically managing...Responsible for compliance with the provisions of the Safe Medical Device Act and providing the necessary… more
- Merck (West Point, PA)
- …as qualification and validation, medical device design controls and device risk management , and design verification/ validation. + Demonstrated ... Engineering Standards, Key Performance Indicators (KPI), Leadership Project Management , Management Process, Manufacturing Scale-Up, Medical Devices , … more