Regulatory Affairs Manager

🕒 August 26

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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INSIGHTEC

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏭 Manufacturing

🏥 Healthcare

💊 Pharmaceuticals

💰 $100M Debt Financing on 2022-08

Manufacturing • Healthcare • Pharmaceuticals

INSIGHTEC is a company pioneering the use of incisionless focused ultrasound technology to treat neurological disorders such as Essential Tremor and Tremor-Dominant Parkinson’s Disease. Their Exablate Neuro platform allows for precision treatment that is incision-free, guided by MRI and offers real-time safety monitoring, often with immediate results and minimal risks. By targeting specific areas of the brain with acoustic energy, they provide a non-invasive alternative to traditional neurosurgery, promoting life-changing transformations for patients all over the world. INSIGHTEC is committed to advancing healthcare innovation and improving patient care through this transformative technology.

📋 Description

• Prepare and maintain clinical regulatory submissions for INSIGHTEC products in relevant markets • Review clinical documents for regulatory appropriateness • Review data and reports incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity • Serve as US Agent for Insightec • Manage cross-functional processes supporting Regulatory, Clinical, and post-marketing activities • Manage annual renewals of establishment registrations, device listings, and other regulatory licenses • Review customer complaints to determine reportability according to regulatory requirements • Provide ongoing regulatory support and assessments for promotional materials • Maintain company knowledge of new standards, guidance, regulations, and applicable standards to ensure regulatory compliance • Support external and internal audits at headquarters and globally • Collaborate with R&D, Clinical, Quality, and Marketing teams locally and globally • Work according to Insightec quality policies, procedures, standards, and privacy and safety rules

🎯 Requirements

• B.Sc. degree in scientific / technical discipline / engineering • Project Management skills • A minimum of 6 years of hands-on experience with medical devices clinical submissions, including IDE/IND, ITA/CTA, EU CTAs • Strong verbal and written communication skills • Ability to work with cross-functional global teams • Experience with Class III products (advantage) • Being introduced by an Insightec employee (advantage)

🏖️ Benefits

• Flexible work environment • Life-work balance philosophy • Competitive perks and benefits in each region • Professional growth and internal talent development opportunities