Senior Manager, Regulatory Affairs - In Vitro Diagnostics and Companion Diagnostics
3 days ago
🇺🇸 United States – Remote
🌽 Illinois – Remote
💵 $117.5k - $223.5k / year
⏰ Full Time
🟠 Senior
🚔 Compliance
🦅 H1B Visa Sponsor
Description
• Works with internal and external partners to deliver products to patients • Supports regulatory objectives for device/combination products • Manages global submissions and CE technical files • Develops device strategies for meetings with regulatory agencies
Requirements
• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, engineering, or related subject • 8+ years of industry experience with IVD, companion diagnostics, medical devices, or combination products • 5+ years in quality systems or cross-functional project management • Demonstrated success in securing regulatory clearance/approvals for IVD products
Benefits
• Comprehensive package of benefits • Paid time off (vacation, holidays, sick) • Medical/dental/vision insurance • 401(k) eligibility • Participation in short-term incentive programs • Participation in long-term incentive programs
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