Principal Regulatory Affairs Specialist

🔥 0 minutes ago

🌽 Illinois, Massachusetts – Remote

🌽 Illinois – Remote 🍂 Massachusetts – Remote

💵 $80.9k - $127k / year

⏰ Full Time

🔴 Lead

🚔 Compliance

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Cardinal Health

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1971

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $78M Post-IPO Debt on 2006-08

Healthcare Insurance • Pharmaceuticals

Cardinal Health is a global healthcare services and products company. It provides a comprehensive range of healthcare services, including medical supply distribution, pharmaceutical distribution, and logistics solutions to various healthcare facilities such as hospitals, community health centers, and ambulatory surgery centers. Additionally, Cardinal Health offers a variety of medical products and pharmaceutical services. The company also focuses on innovative solutions to enhance healthcare delivery, through services like patient support, pharmacy management, and advanced therapy solutions. Cardinal Health is committed to supporting healthcare providers in delivering quality patient care while optimizing operational efficiency.

📋 Description

• Lead new and modified product development projects to establish and integrate regulatory strategy into project activities. • Lead the preparation, submission, and maintenance of global product registrations with a focus on 510(k), EU Technical Documents, and International STEDs. • Collaborate with internal Cardinal Health international regulatory departments to assess international registration requirements, develop international regulatory strategy, and ensure timely execution. • Review design control documents including documents associated with design inputs and design outputs. • Review product labeling for compliance with global labeling regulations. • Interpret and evaluate proposed regulations for medical devices and advise on impact of such regulations to the business. • Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies. • Maintain and provide regulatory information in support of customer queries, bid and tender submissions, customs queries, etc. • Development and implementation of regulatory procedures and SOPs.

🎯 Requirements

• Bachelor’s Degree in a scientific discipline or equivalent work experience, preferred. • 5+ years regulatory affairs experience preferred. • Experience in medical device industry a plus. • Proficiency in US and Europe medical devices regulations highly preferred. • Strong organizational and problem-solving skills. • Strong oral and written communication skills. • Ability to manage multiple projects while maintaining deadlines. • Ability to travel up to 10% of the time.

🏖️ Benefits

• Medical, dental and vision coverage • Paid time off plan • Health savings account (HSA) • 401k savings plan • Access to wages before pay day with myFlexPay • Flexible spending accounts (FSAs) • Short- and long-term disability coverage • Work-Life resources • Paid parental leave • Healthy lifestyle programs