Clinical Affairs Specialist III

🕒 June 3

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Integer Holdings Corporation

WebsiteLinkedInAll Job Openings

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

• Adhere to safety, environmental, security and quality requirements • Contribute to global clinical strategies for product submissions • Represent Clinical Affairs function on product development teams • Ensure clinical data integrity for regulatory functional group needs • Generate interim and final reports • Support market specific clinical training • Interface with and assure training of investigators and clinical affairs staff • Support monitoring of all clinical trials • Work with regulatory bodies for approvals and queries • Support development of Integer technology including scope, budget, and schedule

🎯 Requirements

• Degree from higher education in Science, Engineering, Health Science, Nursing or related field • 3 years of documented professional experience; or 5-7 years if a degree is not a prerequisite • Experience in medical device or pharmaceutical industry • Familiarity with US and international medical device regulatory submissions/approvals • Knowledge of implantable devices or other high risk device types • Suitable qualifications per MEDDEV 2.7.1 (rev 4) • Experience with research methods, information management, literature reviews, technical writing • Knowledge of various medical device regulations • Experience working with the medical community including physicians • Knowledge of feasibility, pivotal, and post market clinical trials • Experience in ERP systems (Oracle, Reliance, etc.), Minitab, Excel

🏖️ Benefits

• Health insurance • Dental insurance • Vision insurance • Disability insurance • Life insurance • Adoption benefits • Parental leave after one year • 401(k) plan with company matching contributions • 80 hours of company designated holidays per year • Annual allotment of paid time off