- Omnicell (Pittsburgh, PA)
- …experience in a leadership role + Strong understanding of medical device design, regulatory processes, system integration, and standards like FDA QSR and ISO ... integrating various engineering disciplines, and ensuring compliance with stringent regulatory and quality standards. You will collaborate with cross-functional… more
- J&J Family of Companies (West Chester, PA)
- …+ Works with design engineers, marketing, quality, supply chain, manufacturing, regulatory affairs, Health Care Professionals and other team members to develop ... to the required activities for documents to ensure compliance with MDR; FDA Design Control regulations, and to support 510(k) submissions. + Contributes to… more
- PCI Pharma Services (Philadelphia, PA)
- …procedures, along with all federal, state and local regulations, including OSHA, FDA , cGMP standards and employment law + Demonstrate substantial knowledge of the ... pharmaceutical industry, including cGMP, regulatory compliance, best practices, emerging trends and be the...to ensure alignment across all functional teams. Ensure successful regulatory and customer audits the assigned responsible areas. +… more
- BioLife Plasma Services (Pittsburgh, PA)
- …applying advanced knowledge of emergency care. * Ensures compliance with regulatory standards for plasma collection and maintains detailed documentation. * Manages ... suitability. * Maintains accurate medical documentation, ensuring compliance with regulatory standards. * Supports public health initiatives by participating in… more
- Penn Medicine (Philadelphia, PA)
- …/ Regulatory : Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... Flexible and readily adopts new processes and engages in practice operation changes. + Access Center Responsibilities (if appropriate): Coordinates clinical and administrative aspects of the new patient scheduling encounter. Perform within the expected outcome… more
- Penn Medicine (Bala Cynwyd, PA)
- …/ Regulatory : + Ensure compliance with all applicable federal, state, and local regulatory standards (eg, TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME). + ... Be flexible and readily adopt new processes and engage in practice operation changes. Credentials: + Epic Certifications (Required) + Must successfully complete/pass EPIC schedgistration training/tests Education or Equivalent Experience: + HS Diploma/GED… more
- Envista Holdings Corporation (Quakertown, PA)
- …growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced ... with cross functional teams: mechanical engineering, software engineering, quality engineering, regulatory affairs. + Has developed FMEA, Risk Analysis and Usability… more
- West Pharmaceutical Services (Williamsport, PA)
- …a culture of health and safety in accordance with the highest standards of regulatory compliance. + End to end ownership for the full business value stream. + ... operations; prefer SAP and MS Office applications. + Experience working with ISO9000, FDA and cGMP required. + Ability to read and interpret documents and drawings,… more
- Penn Medicine (Philadelphia, PA)
- …/ Regulatory : + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc) ... Flexible and readily adopts new processes and engages in practice operation changes. Performs duties in accordance with Penn Medicine and entity values, policies, and procedures. Other duties as assigned to support the unit, department, entity, and health… more
- Penn Medicine (Philadelphia, PA)
- …self and assigned area(s) are compliant with all applicable federal, state, and local regulatory standards (ex OSHA, TJC, DOH, FDA , HIPAA, etc.) * Oversees the ... room temperature as needed. * CCA MAs, if applicable as per regulatory guidelines: administers prescribed medications, gives injections and vaccines; reads PPD… more