Senior Manager, Regulatory Affairs - IVD & CDx

6 days ago

πŸ‡ΊπŸ‡Έ United States – Remote

πŸ’΅ $145.4k - $237.2k / year

⏰ Full Time

🟠 Senior

πŸš” Compliance

Apply Now
Logo of Regeneron

Regeneron

10,000+

πŸ’° Post-IPO Equity on 2023-10

Description

β€’ Collaborate on IVD strategy and regulatory pathways β€’ Represent RA IVD on study teams β€’ Manage regulatory submission reviews β€’ Oversee Health Authorities inquiries β€’ Stay updated on IVD regulations β€’ Build relationships with IVD providers β€’ Support RA IVD processes and initiatives

Requirements

β€’ Bachelors degree in Life Sciences, Engineering or related technical field β€’ Minimum 8-10 years’ pharmaceutical or diagnostics industry experience β€’ 3+ years IVD/Medical Device Regulatory Affairs experience β€’ Experience authoring US Medical Device submissions (Q-sub, IDE, 510(k), PMA) β€’ Familiarity with international IVD regulations (IVDR, PMDA, etc.) β€’ Excellent written and verbal communication skills β€’ Experience with companion diagnostic development processes and regulatory filings

Benefits

β€’ health and wellness programs β€’ fitness centers β€’ equity awards β€’ annual bonuses β€’ paid time off

Apply Now

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