Integer Holdings Corporation
10,000+ employees
Founded 1970
⚕️ Healthcare Insurance
💊 Pharmaceuticals
🧬 Biotechnology
💰 Post-IPO Debt on 2023-01
Healthcare Insurance • Pharmaceuticals • Biotechnology
Integer Holdings Corporation is a leading provider of advanced medical device outsourcing services. With a rich history of 80 years, Integer specializes in the design, development, and manufacturing of medical devices and components. It serves major global OEMs by offering a wide range of products such as finished device systems, Class III Medical Devices, and components for cardiac rhythm management, neuromodulation, and vascular health markets. Integer is renowned for its manufacturing excellence, innovation, and commitment to enhancing patient lives through high-quality medical solutions. The company operates globally, providing unique design expertise, comprehensive product development, and strategic partnerships in the medical device industry.
Senior Clinical Affairs Specialist
🔥 0 minutes ago
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Integer Holdings Corporation
10,000+ employees
Founded 1970
⚕️ Healthcare Insurance
💊 Pharmaceuticals
🧬 Biotechnology
💰 Post-IPO Debt on 2023-01
Healthcare Insurance • Pharmaceuticals • Biotechnology
Integer Holdings Corporation is a leading provider of advanced medical device outsourcing services. With a rich history of 80 years, Integer specializes in the design, development, and manufacturing of medical devices and components. It serves major global OEMs by offering a wide range of products such as finished device systems, Class III Medical Devices, and components for cardiac rhythm management, neuromodulation, and vascular health markets. Integer is renowned for its manufacturing excellence, innovation, and commitment to enhancing patient lives through high-quality medical solutions. The company operates globally, providing unique design expertise, comprehensive product development, and strategic partnerships in the medical device industry.
📋 Description
• Ensure successful conduct of clinical programs for Integer technologies • Support compliance with regulatory, clinical, and standard requirements • Develop global clinical strategies for product submissions • Monitor clinical trials and work with regulatory bodies • Generate interim and final reports • Provide clinical perspective on field complaint investigations
🎯 Requirements
• Degree from higher education (Science, Engineering, Health Science, Nursing or related field) • 5 years of documented professional experience, or 10 years without degree • Experience in medical device or pharmaceutical industry • Experience with implantable devices and/or high-risk device types • Qualified per MEDDEV 2.7.1 (rev 4) • Strong knowledge of medical device regulations • Experience with feasibility, pivotal and post-market clinical trials • Working knowledge with ERP systems (Oracle, Reliance) • Experience with Minitab, Excel • Strong leadership skills
🏖️ Benefits
• Health insurance • Retirement plans • Paid time off • Professional development opportunities
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