6 days ago
πΊπΈ United States β Remote
π΅ $145.4k - $237.2k / year
β° Full Time
π Senior
π Compliance
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
β’ Bachelors degree in Life Sciences, Engineering or related technical field β’ Minimum 8-10 yearsβ 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
β’ health and wellness programs β’ fitness centers β’ equity awards β’ annual bonuses β’ paid time off
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β° Full Time
π Senior
π Compliance
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Compliance Manager supporting Governance and Strategic Operations in a biotech company.
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π° Post-IPO Debt on 2022-12
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π΄ Lead
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π Compliance
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β° Full Time
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π Senior
π Compliance
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