Manager/ Sr. Manager, Regulatory Affairs

Nur für registrierte Mitglieder

San Diego (CA)

Vor Ort

USD 130.000 - 190.000

Vollzeit

Vor 30+ Tagen

Zusammenfassung

An established industry player seeks a Regulatory Affairs Manager to lead a team in ensuring compliance with regulatory standards for innovative diagnostic products. This role involves developing regulatory strategies, managing submissions, and collaborating with various departments to support product launches. The ideal candidate will have extensive experience in regulatory affairs, particularly in IVD, and a strong track record of obtaining approvals in major markets. Join a company committed to quality and innovation in diagnostics, where your expertise will play a vital role in improving patient care and outcomes.

Qualifikationen

8+ years in Regulatory Affairs, with 5+ years in IVD Regulatory Affairs.
Strong knowledge of regulatory approvals and IVD product development.

Aufgaben

Manage regulatory plans and submissions for IVD products.
Coordinate with cross-functional teams for new product development.

Kenntnisse

Regulatory Requirements Knowledge

IVD Product Development

Verbal Communication

Written Communication

Ausbildung

Bachelor’s degree in bioengineering/biomedical engineering

Advanced degree preferred

Regulatory Affairs Certification

Jobbeschreibung

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Deine Position

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Dein Profil

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Leistungen

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sed quia consequuntur magni dolores eos qui ratione voluptatem sequi nesciunt.
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