- Penn Medicine (Philadelphia, PA)
- …(The Joint Commission), OSHA (Occupational Safety and Health Act), NRC (Nuclear Regulatory Commission), DEA ( Drug Enforcement Agency), DOT (Dept. of ... Performs teaching functions with residents and Medical Laboratory Science Students. Regulatory Compliance: Works with the Division's Quality Assurance manager in… more
- Penn Medicine (Philadelphia, PA)
- …(The Joint Commission), OSHA (Occupational Safety and Health Act), NRC (Nuclear Regulatory Commission), DEA ( Drug Enforcement Agency), DOT (Dept. of ... Performs teaching functions with residents and Medical Laboratory Science Students. ** Regulatory Compliance:** Works with the Division's Quality Assurance manager in… more
- Pfizer (Collegeville, PA)
- …clinical study reports (CSRs), investigator brochures, statistical analysis plans, and regulatory documents. + Foster a transparent environment that builds strong ... external partners, such as project leaders, research units, biostatistics, regulatory affairs, clinical pharmacology, human genetics, translational oncology, precision… more
- Penn Medicine (Philadelphia, PA)
- …(The Joint Commission), OSHA (Occupational Safety and Health Act), NRC (Nuclear Regulatory Commission), DEA ( Drug Enforcement Agency), DOT (Dept. of ... the Division's Quality Assurance manager in functioning as liaison to accrediting/ regulatory agencies in preparation for inspections, site visits, documentation of… more
- Mallinckrodt Pharmaceuticals (Horsham, PA)
- …but not limited to the following functional areas: Bulk drug substance manufacturing including Upstream Processing, Downstream Processing, and Manufacturing ... and lead strategic initiatives. Demonstrated ability to successfully interact with regulatory agencies and direct experience with site regulatory … 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
- GE HealthCare (State College, PA)
- …to work in the office daily **Preferred Qualifications** + In-depth knowledge of global regulatory standards (eg, FDA , EU MDR, ISO 13485, ISO 14971) + Experience ... field issues, service needs, and product performance. + Partner with Quality, Regulatory , Service, and Engineering teams to investigate and resolve product issues +… more
- Sumitomo Pharma (Harrisburg, PA)
- …submissions. + Participate in all validation activities pertaining to commercial products ( regulatory starting materials, drug substances, and drug ... with multiple therapeutic modalities (eg API, solid dosage, biologics, gene therapies, drug /device combination products) is required. Must be familiar with EMA and … 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
- Biomat USA, Inc. (Fairless Hills, PA)
- …and compliance with all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety ... activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a… more