- Wolters Kluwer (Philadelphia, PA)
- …success managing product line projects, including risk mitigation, regulatory awareness, translating customer needs into business requirements, stakeholder ... and tracking success metrics. * Leverage knowledge of US healthcare government and regulatory published drug information and policy data sources (CMS, FDA , etc.)… more
- Deloitte (Pittsburgh, PA)
- …technologies like GenAI, AI/ML, and automation for analytical methods, manufacturing, regulatory and/or QA/QC + Implementation of regulatory authoring tool(s) ... ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in.../EMA/PMDA regulations, and the structure/content of CMC sections in regulatory submissions (IND, NDA, BLA, MAA) + 1+ years… more
- Teleflex (Wayne, PA)
- …and study analysis through publication of scientific publications and regulatory study reports. Experience and comfort with cross-functional oversight are ... functional budget. * Ensure the team works with the Regulatory lead and Medical Director to create sound ...an investigational device exemption. * Prior working experience with FDA , Notified Bodies, TGA, and other OUS clinical bodies.… more
- Penn Medicine (Philadelphia, PA)
- …methods as required). + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, ... etc) Change Management: + Flexible and readily adopts new processes and is engaged in practice operation changes. **Education or Equivalent Experience:** + HS Diploma/GED **AND** 2+ years medical office experience **OR** 2+ years customer service experience… more
- Charles River Laboratories (Wayne, PA)
- …and troubleshoot laboratory experiments, tests, and procedures within accepted regulatory compliance for the characterization and analysis of biotherapeutics through ... With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… 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 ... framework. + Assures that deliverables meet all relevant quality, safety, regulatory , serviceability, and reliability requirements. + Reviews code proposals and… 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. Additional Department Responsibilities (if applicable): + Coordinate clinical and administrative aspects of referral entry and scheduling support. + Receive information via… more
- Commonwealth of Pennsylvania (PA)
- …You will undergo specialized training and conduct inspections related to Shellfish, FDA Contract Inspections, Farm Labor Camps, Juice HACCP, and any other assigned ... which best describes your claim. + A. I have experience conducting regulatory inspections of various food establishments, food processing facilities and/or retail… more
- Sanofi Group (Pittsburgh, PA)
- …role, the TEM will assist patients and caregivers with accessing Sanofi's FDA -approved 14-day T1D infusion therapy. The CE provides disease and product information ... also ensure full compliance with all corporate and industry policies and legal and regulatory requirements, for all field activities and report all AEs. This is a… more
- Commonwealth of Pennsylvania (PA)
- …in specialized training and inspections for various programs, including Shellfish, FDA Contract Inspections, and HACCP protocols, while also preparing detailed ... which best describes your claim. + A. I have experience conducting regulatory inspections of various food establishments, food processing facilities and/or retail… more