- Philips (New Kensington, PA)
- The Vigilance Manager is a key member of our Sleep & Respiratory Care Post Market Surveillance Operations organization, accountable for managing a team responsible ... conducting initial assessments of reportability, and escalating to the manager when necessary, ensuring comprehensive resolution and effective management of… more
- Cook Medical (Pittsburgh, PA)
- …helping others, and driven by integrity, we invite you to apply. The Manager , Investigations, CAPA and Complaints at Cook MyoSite, Inc. is responsible for overseeing ... all activities performed by the Investigations Writing team. The manager works closely with QA Management to ensure Investigations, CAPAs, and Complaints are… more
- Philips (Murrysville, PA)
- **Sr. Information Security Manager ** **- Murrysville, PA** The Integrated Supply Chain (ISC) Information Security Manager will be responsible for developing, ... such as establishing security architecture compliance with regulations (eg, HIPAA, FDA ) and deploy technologies like firewalls and OT IDS (Operational Tech.… more
- Nammo Defense Systems, Inc (Scranton, PA)
- …Nammo Pocal is looking for an experienced and results-driven Quality Control Manager / ISO Management Representative with 5+ years of leadership experience in ... assurance programs in compliance with ISO 9001, and MIL-STD requirements . Proven success leading cross-functional teams in complex, high-reliability environments,… more
- Sumitomo Pharma (Harrisburg, PA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of Manager of Biostatistics to serve as trial statistician for one or more clinical ... Bayesian Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations is a plus + Advanced proficiency… more
- Deloitte (Pittsburgh, PA)
- …data platforms. Our delivery models are tailored to meet each client's unique requirements . The Team Our AI & Data practice offers comprehensive solutions for ... equitable future of health. Work You'll Do As a Manager you will lead and deliver engagements, or components...ICH guidelines (ie: ICH Q6A, Q7, Q8, Q9, Q10), FDA /EMA/PMDA regulations, and the structure/content of CMC sections in… more
- Fujifilm (Harrisburg, PA)
- …policies. + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements , applicable ISO 13485 standard ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and… more
- Grifols Shared Services North America, Inc (Harrisburg, PA)
- …of technical guidelines to assure execution of regulatory strategies and requirements . This is a fully remote role. **Primary responsibilities:** + Develops ... for regulatory submissions meets the appropriate standards and content requirements including planning and implementation around emerging/changing regulatory … more
- United Therapeutics (Harrisburg, PA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... staff, vendors, contractors & other UT employees supporting PV activities. **Minimum Requirements ** + Education and Experience requirements : + Bachelor's degree… more
- Sumitomo Pharma (Harrisburg, PA)
- …+ Strong understanding of pharmacovigilance regulations and drug safety reporting requirements + Skills in signal detection, risk assessment, and safety data ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more