- Cardinal Health (Harrisburg, PA)
- …maintains security policies and IT compliance programs in alignment with regulatory , legal, and contractual requirements, while collaborating closely with key ... IT operations, projects, and M&A activities are aligned with enterprise standards, regulatory requirements and industry's best practices. In this role, you will have… more
- Penn Medicine (Philadelphia, PA)
- …the Division's Quality Assurance manager in functioning as liaison to accrediting/ regulatory agencies in preparation for inspections, site visits, documentation of ... Federal, State, and local government agencies and professional accrediting agencies' regulatory requirements impacting lab operations including AABB, CMS (Center for… more
- Mallinckrodt Pharmaceuticals (Horsham, PA)
- …and lead strategic initiatives. Demonstrated ability to successfully interact with regulatory agencies and direct experience with site regulatory ... technology transfer, scale-up, testing, and validation requirements.Knowledge of cGMP, FDA , DEA and related international regulations.Quality systems, batch documentation,… more
- Penn Medicine (Philadelphia, PA)
- …all areas of accountability are compliant with all federal, state and local regulatory standards and requirements, including DOH, TJC, FDA , HIPAA, HCFA, DPW, ... supervision and direction in regards to all administrative, financial, regulatory , quality, human resources, patient/employee satisfaction, and clinical aspects for… 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, ... products meet current Good Manufacturing Practices, applicable medical device regulatory requirements, and for supporting business development initiatives. **Job… more
- Sumitomo Pharma (Harrisburg, PA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- University of Pennsylvania (Philadelphia, PA)
- …submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. Our projects occur throughout the ... activities such as: Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions. Communicate with study team members.… more
- University of Pennsylvania (Philadelphia, PA)
- …data quality. It requires adherence to all University of Pennsylvania, IRB, and FDA guidelines and may require working off site and flexible hours. Job Description ... and data entry . Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines . Assure compliance with the protocol and regulatory… more
- GE HealthCare (State College, PA)
- …work instructions, PFMEAs, control plans, and validation protocols. + Ensure compliance with regulatory standards (eg, ISO 13485, FDA QSR) and internal quality ... in an engineering or operations role. + Experience in an ISO13485, FDA regulated or Medical Device manufacturing environment + Strong understanding of ultrasound… more
- Globus Medical, Inc. (Eagleville, PA)
- …manufacture of high-quality products and to facilitate compliance with regulatory requirements. **Essential Functions** **:** + Overseas operations efficiency and ... compliance within company policies and procedures (eg, compliance with FDA , ISO 13485, or other regulations). + Complies with...+ Demonstrated knowledge of ISO and quality systems as FDA and OSHA requirements, as a plus + Experience… more