- Kelly Services (Greenville, NC)
- …eg, pharmaceuticals, manufacturing, etc.]. * Knowledge of regulatory requirements (eg, FDA , EMA, ISO) and industry standards. * Strong analytical and problem-solving ... skills. * Excellent communication and interpersonal skills. * Proficiency in quality management systems (QMS) and relevant software tools. **Preferred Qualifications:** * Certification in Quality Management (eg, Six Sigma, ASQ). * Experience with electronic… more
- Teleflex (Morrisville, NC)
- …well as during audits to mitigate any potential risks. * Interface with FDA , Notified Bodies, or other national health agencies regarding new products and ... significant product changes as needed. * Assume full responsibility for project submissions, from guidance/strategies/authoring/obtaining approvals, including 510(k) premarket notifications, EU MDD/MDR Technical Files, and/or other documentation required for… more
- ZOLL Medical Corporation (Asheville, NC)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the US At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.ZOLL has been… more
- Cytel (Raleigh, NC)
- …team of consultants and analysts. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to enhance development plans. + Collaborative, ... entrepreneurial and self-motivated, with an understanding of the dynamics of high-growth companies; the ability to work effectively in a challenging and sometimes rapidly changing environment. + Minimum of a Masters in Mathematics, Biostatistics, or a related… more
- ThermoFisher Scientific (Greenville, NC)
- …(GCP), with ability to learn and maintain a good working knowledge of FDA regulations and company/client SOPs and WPDs + Strong organizational skills and flexibility ... to manage workload and meet changing timelines, handling multiple tasks efficiently and effectively + Thorough attention to detail to ensure accuracy and efficiency in data entry + Strong interpersonal/customer service skills, positive attitude and good oral… more
- Lilly (Concord, NC)
- …certification in a related field is a plus + Knowledge of FDA and GMP regulations + Experience operating high-speed, automated production equipment, preferably ... Syringe/Vial Filling systems utilizing Isolator technology + Ability to quickly learn and apply new procedures + Experience working in a classified manufacturing environment + Familiarity with Computerized Maintenance Management Systems (CMMS) platforms +… more
- Fujifilm (Raleigh, NC)
- …II + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications:** Professional Experience: + 5-10 years… more
- Chiesi (Cary, NC)
- …professionals + Knowledge and experience in interpreting and adhering to FDA regulations regarding product promotion, scientific exchange, and health care ... practitioner guidelines + Demonstrated proficiency in written, verbal, and face-to-face communications to effectively present information to and influence/support decision-making of managers, working partners, and governmental agencies + Ability to… more
- Fujifilm (Raleigh, NC)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. Key Performance Indicators: + Revenue and sales bookings… more
- Univar Solutions (Jamestown, NC)
- …and preparing branch prior to external Compliance and Quality Audits (Customer, Supplier, FDA or other Agencies, and Associations) + Writing SOPs and creating local ... forms for branch + Collaborate with and back up Operations Supervisors + Manage laboratory operations including equipment calibration, sample management, record keeping and the processing of samples with analytical equipment provided to meet branch and… more