- Community Health Systems (Dunmore, PA)
- …treatment of breast diseases. This role requires advanced technical skills, adherence to FDA /MQSA, ACR, and state regulatory standards, and a strong commitment ... positioning, imaging techniques, and radiation protection. + Strong understanding of FDA /MQSA, ACR, and state regulatory compliance requirements. + Ability… more
- CSL Behring (King Of Prussia, PA)
- …including integrated analyses for submissions. + Represent Biostatistics in interactions with regulatory authorities (eg, FDA , EMA, PMDA) + Be responsible for ... program. The AD provides statistical strategies for the clinical trials and regulatory submissions and is accountable for the statistical deliverables within the… more
- Penn Medicine (Philadelphia, PA)
- …leadership and direction in regards to all administrative, financial, regulatory , quality , human resources, patient/employee satisfaction, and clinical ... all areas of accountability are compliant with all federal, state and local regulatory standards and requirements, including DOH, TJC, FDA , HIPAA, HCFA, DPW,… more
- Pfizer (Collegeville, PA)
- …of related disciplines, eg, Clinical Operations, Safety, Biostatistics, Regulatory , Study Management, Pre-clinical, Pharmacology, Quality Assurance. ... SUMMARY** You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs… 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 ... maintaining a patient/customer focus, supports the delivery of high quality care, shares a passion for patient and customer...Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA,… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …roles and responsibilities and relationship between Olympus and the suppliers. + Ensure regulatory and contractual compliance in accordance to FDA , ISO 13485, ... industry and functional trends by reviewing the output of relevant quality and regulatory intelligence reports and apply learning to target evaluation and… more
- Globus Medical, Inc. (Audubon, PA)
- …records, drafts detailed technical reports, and ensures strict compliance with applicable quality and regulatory standards + Possesses in-depth knowledge of CBER ... sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our...product development strongly preferred + Comprehensive knowledge of GMP, FDA , CBER, and CDRH regulatory requirements +… more
- Penn Medicine (Philadelphia, PA)
- …Performs teaching functions with residents and Medical Laboratory Science Students Regulatory Compliance: Works with the Division's Quality Assurance manager ... Assumes overall responsibility for the formulation and monitoring of a Quality Control/ Quality Improvement program; takes responsibility for staff errors;… more
- Penn Medicine (Philadelphia, PA)
- …execution of day-to-day operations for the department. Ensures consistent delivery of high- quality patient care and services as a trusted advisor to the department ... and innovative for patient needs. DOO ensures compliance with regulatory bodies. **Responsibilities:** Department Strategic Planning & Change Management: +… more
- Teleflex (Wyomissing, PA)
- …Experience with documentation, method optimization, and cross-functional collaboration. * Familiarity with regulatory and quality frameworks (eg, FDA 21 CFR ... method development, and medical device evaluation, ensuring compliance with protocols, quality systems, and regulatory requirements. * Prepare, optimize, and… more