- Edwards Lifesciences (Greensboro, NC)
- …Our other star player? You! IHFM has achieved a significant milestone and received FDA approval for our Cordella PA Sensor. Join us as we commercialize this ... revolutionary heart failure management system! As the Area Sales Manager at IHFM, you will play a pioneering role in driving the adoption and growth. You will lead the charge in establishing IHFM's presence in **North Carolina** within the healthcare… more
- Insight Global (Sanford, NC)
- …environments. Familiarity with capital project workflows and documentation control. Knowledge of GMP, FDA , or other regulatory environments is a plus null We are a ... company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will… more
- Dentsply Sirona (Charlotte, NC)
- …documentation, including 510(k) submissions and CE marking + In-depth knowledge of FDA regulations and international standards (eg, ISO 13485) **Key Required Skills, ... Knowledge, and Capabilities:** + Proficiency with Microsoft Office Suite + Proficiency with Regulatory software + Strong leadership, attention to detail and organizational skills + Excellent communication and interpersonal skills + Ability to work effectively… more
- VTI Life Sciences (Raleigh, NC)
- …site regulatory inspections + SME for presentation of cleaning validation to Regulatory ( FDA ), internal and external auditors. + Identify all necessary SOPs and need ... by dates and work with owning functions to ensure delivery + Work in partnership with QC teams to determine the appropriate CV methods and sampling strategies + Work in partnership with the Supply Chain teams to develop a material resourcing and storage… more
- CSL Plasma (Winston Salem, NC)
- …donor disconnect. * In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. * Evaluates ... vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the… more
- Chiesi (Cary, NC)
- …newly created position will initially focus on pre-launch preparation in anticipation of FDA approval of our global market leading product, Trimbow(R). We want to ... find an experienced marketer with the skills, experience, and passion to help us fulfill our mission of helping to introduce Chiesi and our products to the US asthma and COPD respiratory community. This position will guide key commercial projects to engage… more
- Cardinal Health (Raleigh, NC)
- …False Claims Act, Civil Monetary Penalties Law, Stark, Beneficiary Inducement Statutes), FDA regulation (Food, Drug & Cosmetic Act), and privacy (HIPAA). * Draft, ... negotiate and review a wide range of agreements, including complex matters relating to manufacturer supply agreements and co-marketing arrangements. * Advise and ensure that internal clients receive sound, practical and timely legal advice on a wide variety of… more
- ThermoFisher Scientific (Greenville, NC)
- …improvements and efficiencies. + Coordinate regulatory inspections performed by the FDA , MCA, and other agencies. + Defend policies, procedures, rationales, and ... methods during regulatory and client audits. + Establish and supervise quality programs and plans, such as validation, QAT, and supplier certification. **Qualifications:** + High School Diploma or equivalent experience required. + Bachelor's degree in… more
- Compass Group, North America (Charlotte, NC)
- …wellness related programs and initiatives and to ensure compliance with FDA nutrition labeling laws. **Key Responsibilities:** + Coordinates and implements sector ... specific nutrition and wellness programs and initiatives. + Participates in account retention and sales efforts as well as quarterly business reviews. + Develops and presents materials for wellness programs including health fairs, lunch and learns, program… more
- Cardinal Health (Raleigh, NC)
- …investigators participating in ongoing studies + Maintain current knowledge of FDA regulations and internal policies regarding Medical Drug Information, including ... any MSL presentations and Medical/Safety Review Committees + Provides pharmacovigilance support through collaboration with other internal stakeholders by collecting adverse event information, facilitating investigations of safety events, and identifying… more