- Mallinckrodt Pharmaceuticals (Horsham, PA)
- …technology transfer, scale-up, testing, and validation requirements.Knowledge of cGMP, FDA , DEA and related international regulations. Quality systems, batch ... and lead strategic initiatives. Demonstrated ability to successfully interact with regulatory agencies and direct experience with site regulatory … more
- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …timelines to ensure compliance with labeling regulations and guidance. Delivers high- quality submission labeling and artwork for complex drug products, specific ... to drive alignment of labeling content and strategy. + Partner with Global Regulatory Affairs to ensure that all labeling is aligned with the product global… more
- Wolters Kluwer (Philadelphia, PA)
- …engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA , EU MDR, ISO 13485, and IEC 62304. ... and managing the software development plan and partnering with engineering, quality , and regulatory team members to aligning the process with agile and lean… more
- Globus Medical, Inc. (Eagleville, PA)
- … requirements + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other … more
- GE HealthCare (State College, PA)
- …protocols. + Ensure compliance with regulatory standards (eg, ISO 13485, FDA QSR) and internal quality systems. + Manage capital equipment selection, ... role is responsible for driving process improvements, ensuring product quality , supporting new product introductions, and leading cross-functional initiatives to… more
- Eurofins US Network (Lancaster, PA)
- …environment. This role ensures timely delivery of testing services, adherence to regulatory standards ( FDA , EMA, ICH), and effective communication with internal ... ability to manage complex projects and cross-functional teams. + Familiarity with regulatory requirements and quality standards. + Excellent communication and… more
- Edwards Lifesciences (Harrisburg, PA)
- …+ Proficient in SAS; experience with R, S-Plus + Thorough understanding of regulatory guidelines (GCP, ICH, FDA , ISO) for pharma/medical devices + Excellent ... evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help… more
- CSL Behring (King Of Prussia, PA)
- …and regulatory submissions. Be accountable for timely completion and quality of the statistical analysis plan. Support Biostatistics interactions with ... regulatory authorities (eg FDA , EMA, PMDA) Be...statistical programmers within the responsible projects. Ensure timeliness and quality of deliverables by CRO/FSP. Conduct reviews of deliverables… more
- Penn Medicine (West Chester, PA)
- …services, and technologies, ensuring that clinical input and safety, regulatory , and epidemiological considerations are incorporated before decisions are made. ... + Continuously communicates at all levels the importance of patient satisfaction, quality of care, and sound financial performance and champions successes and… more
- BD (Becton, Dickinson and Company) (Zelienople, PA)
- …personnel. + Experience with drafting/CAD/3D modeling a plus. + Familiarity with FDA regulatory requirements, GMP, ISO, lean, process validation and six ... equipment/process and support systems to meet product requirements, regulations, quality and company policies. + Lead the validation/qualification effort for… more