Director, Clinical Evaluation and Excellence

Job not on LinkedIn

November 26

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

🍂 Massachusetts – Remote

Although this job is listed in Massachusetts, this company may be open to hiring remote in other states.

💵 $183.2k - $274.8k / year

⏰ Full Time

🔴 Lead

👔 Director

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Diabetes Youth Families

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Healthcare Insurance • Hardware

Diabetes Youth Families is a company that provides wearable insulin delivery solutions for diabetes management. Their primary products, such as the Omnipod 5 and Omnipod DASH systems, offer tubeless and automated insulin delivery for people with Type 1 and Type 2 diabetes, allowing users to manage their condition without the need for multiple daily injections. The systems integrate with continuous glucose monitoring (CGM) devices and can be controlled via compatible smartphones, enhancing the freedom and lifestyle of individuals living with diabetes. With a focus on reducing the burden of diabetes management, they offer financial assistance, support resources, and trial programs to help users adapt to their innovative solutions. The company emphasizes making life simpler while managing diabetes through technology-driven insulin management systems.

11 - 50 employees

Founded 1938

⚕️ Healthcare Insurance

🔧 Hardware

📋 Description

• Provide strategic oversight of clinical research studies globally to ensure regulatory compliance • Lead global regulatory submissions and safety reporting across pre-market and post-market clinical research studies • Oversee the development of documents to meet EU MDR requirements • Conduct gap analyses and implement procedural updates based on evolving regulations • Ensure timely and accurate global safety reporting in compliance with 21 CFR 803, ISO 14155, and MDCG guidance • Manage and mentor a team of regulatory specialists, clinical writers, quality specialists and safety professionals

🎯 Requirements

• Bachelor’s degree in Life Sciences or related field (advanced degree preferred) • Minimum 10 years of experience in clinical research, regulatory affairs, and quality assurance within the medical device industry • Proven leadership in global regulatory strategy and clinical documentation • Excellent communication, leadership, and project management skills.

🏖️ Benefits

• Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs