Senior Manager Regulatory Affairs

Company: VirtualVocations
Location: Long Beach
Posted on: November 8, 2024

Job Description:

A company is looking for a Senior Manager, Regulatory Affairs IVD & CDx.

Key Responsibilities

Develop and execute IVD strategy in collaboration with stakeholders
Coordinate and manage regulatory submissions and inquiries
Maintain relationships with IVD providers and project teams

Required Qualifications

Bachelor's degree in Life Sciences, Engineering, or related field
8-10 years of experience in the pharmaceutical or diagnostics industry
3+ years of IVD/Medical Device Regulatory Affairs experience
Experience with US Medical Device submissions (Q-sub, IDE, 510(k), PMA)
Familiarity with international IVD regulations and global registrational processes

Keywords: VirtualVocations, Buena Park , Senior Manager Regulatory Affairs, Executive , Long Beach, California

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