- ZOLL Medical Corporation (Pittsburgh, PA)
- …required + Experience in an FDA regulated Class III electrical medical device manufacturing environment preferred.preferred and + Experienced in process ... to understand the appropriate legal and regulatory requirements in the areas of medical device operations and to establish robust processes and controls to… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …in order to meet regulatory/ procedural deadlines. + Demonstrated working knowledge of Medical Device Quality Systems regulations including ISO 13485, ... (https://www.olympusamerica.com/careers) . **Job Description** Responsible for the review of medical device global complaints and coordinate the resolution… more
- PCI Pharma Services (Philadelphia, PA)
- …+ Demonstrated expertise in quality management systems and regulatory requirements ( FDA , ISO 13485, Medical Device Directive) + Strong knowledge ... to pioneer and shape the future of PCI. The ** Quality Systems Manager** is responsible for overseeing and maintaining...identify patterns requiring systemic solutions + Ensure compliance with FDA regulations, ISO 13485, Medical Device… more
- Globus Medical, Inc. (Audubon, PA)
- …is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within orthopedic medical devices; + ... At Globus Medical , we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- … devices in domestic and international markets. + Post-market surveillance and medical device reporting in domestic and international markets + Responsible ... innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and… more
- Envista Holdings Corporation (Quakertown, PA)
- …regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field. A friendly and open atmosphere helps to foster ... fields required. + 1+ years of experience in progressive Quality Assurance role and exposure to FDA ...and cooperation. + Experience and working knowledge of electrical medical device manufacturing (preferred). + Experience with… more
- West Pharmaceutical Services (Exton, PA)
- …of quality -related experience with preferred experience in pharmaceutical and/or medical device industry + Expertise of cGMP requirements, ISO standards ... team members are trained in GMP-relevant topics and ensuring compliance with quality system documents, cGMPs, ISO standards, and FDA regulations. **Education**… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and ... (https://cardiacdiagnostics.zoll.com/products/heart-failure-arrhythmia-management-system/) (Heart Failure Management system) is a non-invasive, patch-based device that monitors pulmonary fluid levels and has been… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …control). + Minimum of 2 years Medical Safety, risk management Vigilance or other Medical Device Experience ( Medical Device preferred to Pharma) OR ... Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal,...Progressive leadership experience in the health care setting. + Medical Safety ( Medical Device preferred… more
- Globus Medical, Inc. (Audubon, PA)
- …or equivalent work experience + 5+ years of related experience in the medical device industry + Understanding of regulatory requirements throughout the product ... At Globus Medical , we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team… more