- Cardinal Health (Harrisburg, PA)
- **_What Regulatory Submissions Operations contributes to Cardinal Health_** Regulatory Submissions Operations provides regulatory affairs and product ... services to enable pharmaceutical, medical and biotechnology companies to obtain regulatory approvals. More specifically, this role serves the function to support… more
- UPMC (Greensburg, PA)
- …Assists at other UPMC Radiation Oncology locations if the need arises. + ** Regulatory Affairs Management** : Participates in regulatory compliance activities ... and maintains continuous departmental readiness for inspections and surveys. Follows all radiation safety standards. Wears radiation monitoring badge and ID badge at all times. Remains HIPAA compliant at all times. Completes clinical competencies annually as… more
- PNC (Pittsburgh, PA)
- …Corporate and Institutional Banking Risk + Operational Risk Management + Credit Risk + Regulatory Affairs + Enterprise Compliance + Retail Risk + Enterprise Risk ... Mortgage Licensing Act of 2008 (SAFE Act) and/or the Financial Industry Regulatory Authority (FINRA), which prohibit the hiring of individuals with certain criminal… more
- Envista Holdings Corporation (Quakertown, PA)
- …with cross functional teams: mechanical engineering, software engineering, quality engineering, regulatory affairs . + Has developed FMEA, Risk Analysis and ... growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced… more
- J&J Family of Companies (Horsham, PA)
- …interactions with the global functions including clinical R&D, translational medicine, regulatory affairs /labelling, and global medical safety. This includes ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Affairs - MD **Job… more
- University of Pennsylvania (Philadelphia, PA)
- …regulations, GCP and IND/IDE in both adult and pediatric research. Must understand regulatory affairs and their applications to Quality Control and Quality ... the year. This allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with family-whatever your personal needs… more
- Globus Medical, Inc. (Audubon, PA)
- …resume their lives as quickly as possible. **Position Summary** **:** The Senior Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) ... study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting...and PMA reporting + Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes + Performs… more
- Kiewit (Pittsburgh, PA)
- …Strong public speaking skills * Environmental experience in policies and procedures, regulatory affairs , permitting, due diligence, and auditing * Strong ... emphasis on employee training. **Qualifications** * 10+ years' environmental regulatory experience managing and implementing environmental programs * Undergraduate… more
- Sumitomo Pharma (Harrisburg, PA)
- …but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs , Data Management and Biostatistics is essential. ... as required. + Coordinate responses to ad hoc safety issues such as regulatory authority, site, or health care professional requests, along with PV physician,… more
- Organon & Co. (Plymouth Meeting, PA)
- …core labeling documents (CCDS) and US labeling for marketed products; and supporting country Regulatory Affairs in the development and maintenance of the EU and ... labeling documents for company products, including Core, US and supporting country regulatory affiliates for consistency of labeling documents around the world. +… more