3 jobs found in Hampton

About Celldex Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive-focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day. Overview The Associate Director, Quality Medical Device Engineer will lead quality oversight activities for drug-device combination products, including prefilled syringes, autoinjectors, on-body delivery systems, and related medical device...

Duration: 12 months with extension options up to 5 years Work Schedule: Full-time, 40 hours weekly | Monday - Friday, 07:30 AM - 04:30 PM Key Responsibilities Provide medical coding training and ongoing support within the healthcare environment. Support coding education, staff training, and professional development activities. Apply knowledge of professional, institutional, and clinical documentation coding practices. Promote accurate, consistent, and compliant coding practices in accordance with applicable requirements. Provide guidance and instruction on clinical documentation and medical coding processes. Collaborate with healthcare providers, coding personnel, and administrative staff to support coding accuracy and consistency. Maintain professional standards and comply with applicable Department of Defense (DoD) and Defense Health Agency (DHA) policies and procedures. Complete all required agency and facility-specific training and adhere to applicable...

Overview The Associate Director, Quality Medical Device Engineer will lead quality oversight activities for drug-device combination products, including prefilled syringes, autoinjectors, on-body delivery systems, and related medical device constituents. This position will partner closely with Technical Operations, Device Development, Regulatory Affairs, Clinical, Supply Chain, and external manufacturing partners to establish and maintain compliant quality systems and ensure the successful development and commercialization of combination products. Responsibilities Serve as the Quality lead and Subject Matter Expert (SME) for combination product and medical device constituent quality activities. Provide strategic oversight of combination product development programs from concept through commercialization. Ensure compliance with FDA 21 CFR Part 4, 21 CFR Part 820/Quality Management System Regulation (QMSR), applicable ISO standards, EU MDR requirements, and other relevant...