- Integra LifeSciences (Plainsboro, NJ)
- …chance to do important work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To us, change equals opportunity. Every ... in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device...13485, the medical device directive, and the other applicable regulatory agencies. Expectations are to be familiar with and… more
- Integra LifeSciences (Plainsboro, NJ)
- …chance to do important work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To us, change equals opportunity. Every ... in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device...13485, the medical device directive, and the other applicable regulatory agencies. Expectations are to be familiar with and… more
- Integra LifeSciences (Plainsboro, NJ)
- …chance to do important work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To us, change equals opportunity. Every ... in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device...13485, the medical device directive, and the other applicable regulatory agencies. Expectations are to be familiar with and… more
- Integra LifeSciences (Plainsboro, NJ)
- …you to do important work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To us, change equals opportunity. Every ... all established costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the… more
- Integra LifeSciences (Plainsboro, NJ)
- …chance to do important work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To us, change equals opportunity. Every ... in accordance to the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device...13485, the medical device directive, and the other applicable regulatory agencies. Expectations are to be familiar with and… more
- Integra LifeSciences (Plainsboro, NJ)
- …chance to do important work that creates change and shapes the future of healthcare . Thinking differently is what we do best. To us, change equals opportunity. Every ... all established costs, quality, and delivery commitments are met, working within FDA medical device regulations, and applicable ISO standards. + Responsible for the… more
- Merck (Rahway, NJ)
- …oversight of DS & cell banking process development, process characterization and regulatory filing activities to ensure a smooth and clear path to successful ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + **CMC RA** : Experience supporting/writing … more
- Penn Medicine (Plainsboro, NJ)
- …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
- Sumitomo Pharma (Trenton, NJ)
- …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
- Merck (Rahway, NJ)
- …Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + **CMC RA** : Experience supporting/writing … more