- PCI Pharma Services (Philadelphia, PA)
- …systemic solutions + Ensure compliance with FDA regulations, ISO 13485, Medical Device Directive, and other applicable standards and regulations **Corrective ... in quality management systems and regulatory requirements (FDA, ISO 13485, Medical Device Directive) + Strong knowledge of cGMP and other applicable… 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 ... problem-solving and cooperation. + Experience and working knowledge of electrical medical device manufacturing (preferred). + Experience with SAP is… more
- ThermoFisher Scientific (Pittsburgh, PA)
- …13485, IVDR, cGMP's, FDA Guidelines, USP, and GxP. + Detailed knowledge of medical device manufacturing processes and experience with risk management regulations ... training content for IT Systems used by Quality and Regulatory . + Analyze Quality and Compliance processes,...Quality and Regulatory . + Analyze Quality and Compliance processes, translate Quality and Regulatory requirements… 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. ... of Post Market Surveillance/C&R teams, detailed knowledge in FDA and Global Medical Device regulations, strong communication and collaboration skills, with a… more
- Penn Medicine (Lancaster, PA)
- …leaders in the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and business professionals across ... such as electromagnetic and infrared-based systems, to guide catheter and device placement during procedures, ensuring optimal accuracy and patient safety. +… more
- ThermoFisher Scientific (Philadelphia, PA)
- …organizational expertise, and **_deep industry knowledge across the pharmaceutical, biotech, or medical device sectors_** , along with a proven track record ... key account management in a related Pharmaceutical, Biotech or Medical Device sales industry + Experience in...+ Awareness of regulatory landscape, including understanding regulatory bodies, compliance requirements, and any changes… more
- Omnicell (Pittsburgh, PA)
- …various Engineering and Quality teams, creation and maintenance of documentation, and ensuring compliance with relevant medical device regulations + Other ... field, with prior experience in a leadership role + Strong understanding of medical device design, regulatory processes, system integration, and standards… more
- Penn Medicine (Philadelphia, PA)
- …IS Application teams as needed to address complex technical issues maintaining compliance with regulatory standards such as HIPAA. Understands integration ... the field of medicine. Working for this leading academic medical center means collaboration with top clinical, technical and...teams as needed to address complex technical issues maintaining compliance with regulatory standards such as HIPAA.… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …experience, including a minimum of 5-7 years in the pharmaceutical/biotechnology or medical device industry. + In-depth knowledge of (US) healthcare systems, ... analysis, econometric modelling, and real-world outcomes research in the pharmaceutical/biotechnology or medical device industry. + Senior level competence in US… more
- West Pharmaceutical Services (Williamsport, PA)
- …or management role. + Proven experience working in the ** medical device industry** with a strong understanding of regulatory requirements (FDA, ISO ... for developing, optimizing, and maintaining robust injection molding processes for medical device manufacturing. This role requires deep technical expertise… more