Associate Director, Regulatory Affairs – In Vitro Diagnostics, Digital Health

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $179.6k - $293k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 Post-IPO Equity on 2023-10

Healthcare • Manufacturing • Biotechnology

Regeneron is a biotechnology company dedicated to turning scientific discoveries into life-changing medicines. The company focuses on a range of serious diseases including allergic, cardiovascular, and metabolic diseases, neuroscience, oncology, hematology, ophthalmology, and rare diseases. It achieves this by integrating biology and technology to develop cutting-edge biologics and genetic medicines. Regeneron is committed to health equity, environmental sustainability, and supporting future STEM talent through initiatives like the Regeneron Science Talent Search. By maintaining high ethical standards and corporate responsibility, Regeneron aims to push the boundaries of science for better healthcare solutions.

📋 Description

• Support device regulatory strategies across development, submissions, and commercialization • Coordinate regulatory pathways, development timelines, and commercialization plans • Lead health authority meetings covering In Vitro Diagnostics and Digital Health Technology • Present regulatory positions during agency interactions and discussions • Communicate critical program updates and regulatory risks to senior management • Build relationships with internal stakeholders and external device development partners • Monitor emerging technologies and global regulations impacting diagnostics and digital health

🎯 Requirements

• Bachelor’s degree in a scientific discipline • 8 years of pharmaceutical or medical device industry experience • 5+ years of Medical Device/In Vitro Diagnostics regulatory affairs experience • Experience with U.S. medical device submissions, including pre-submissions, Investigational Device Exemption (IDE), 510(k), and Premarket Approval (PMA) • Experience with international device regulations, including Medical Device Regulation/In Vitro Diagnostic Regulation (MDR/IVDR) and PMDA requirements • Knowledge of Companion Diagnostics, In Vitro Diagnostics, and Digital Health Technology regulations • Strong project management skills • Strong written and verbal communications skills • Ability to collaborate and influence

🏖️ Benefits

• Annual bonuses or other incentive plans • Equity awards • Pension or retirement benefits • 401(k) company match • Health and wellness programs • Fitness centers • Medical, dental, vision, life and disability insurance benefits • Paid time off • Family support benefits • Reasonable accommodation for applicants with known disabilities or chronic illnesses

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