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Clinical Affairs Program Manager

Irvine, CA

🔒 Direct submission to hiring team • Zero candidate fees

Role & Company Overview

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Employer
JCW
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Location / Model
Irvine, CA
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Employment
Full-Time
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Recruitment Type
Direct to HR Pipeline
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Industry
General
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Company Size
🌐
Headquarters
United States
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Visa & Sponsorship
Global Talent Consideration
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Global Sponsorship Signal: This position is eligible for global talent consideration and work authorization sponsorship for top qualified international candidates.
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Human-Verified Opening: Inspected by Sarah Jenkins, CIPD • Hirely Editorial Team. Authenticated directly from JCW's hiring pipeline • Zero recruiter markups or candidate fees. Verification Standards

📋 Role Overview & Responsibilities

Apply for an exciting opportunity to join a global Medical Device company. You will be writing many CERs for existing products in line with EU MDR guidelines and contribute to the clinical strategy for new products.

RESPONSIBILITIESCreate and manage detailed project schedule, timelines and project tracking tools for Clinical Evaluation, PMS and Post Market Clinical Follow-up (PMCF) processes for all medical devices and IVDs. Ensure, in conjunction with R&D and other personnel, that the clinical requirements of the product are adequately addressedManage relationship with CROs, as applicable

EXPERIENCEA minimum of 4 years of combined experience in clinical research, medical writing, clinical science in the medical device and/or pharmaceutical industry. Master's degree or Ph. D. preferred. Experience/knowledge in writing CERs and/or PMS plans in accordance with Meddev 2.12.2 and MDR

Frequently Asked Questions

How do I apply for the Clinical Affairs Program Manager position at JCW? ▼

Click the “Apply for this Position” button on this page to submit your application directly to JCW without recruitment intermediary fees.

Is this position eligible for remote work or visa sponsorship? ▼

This position is located in Irvine, CA with potential relocation and sponsorship assistance depending on candidate qualifications.

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