Diabetes Youth Families
Supporting those affected by type 1 diabetes so they may lead full, healthy, beautiful lives, NOW.
Director, Clinical Evaluation and Excellence
Location
California + 1 moreAll locations: California, Massachusetts
Posted
103 days ago
Salary
$183.2K - $274.8K / year
Bachelor Degree10 yrs expEnglish
Job 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
Job 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
