Senior Manager, Regulatory Affairs - IVD & CDx
October 31
🇺🇸 United States – Remote
💵 $145.4k - $237.2k / year
⏰ Full Time
🟠 Senior
🚔 Compliance
🗽 H1B Visa Sponsor
Description
• Collaborate on IVD strategy and regulatory pathways • Represent RA IVD on study teams • Manage regulatory submission reviews • Oversee Health Authorities inquiries • Stay updated on IVD regulations • Build relationships with IVD providers • Support RA IVD processes and initiatives
Requirements
• Bachelors degree in Life Sciences, Engineering or related technical field • Minimum 8-10 years’ pharmaceutical or diagnostics industry experience • 3+ years IVD/Medical Device Regulatory Affairs experience • Experience authoring US Medical Device submissions (Q-sub, IDE, 510(k), PMA) • Familiarity with international IVD regulations (IVDR, PMDA, etc.) • Excellent written and verbal communication skills • Experience with companion diagnostic development processes and regulatory filings
Benefits
• health and wellness programs • fitness centers • equity awards • annual bonuses • paid time off
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