Director, Quality & Regulatory Affairs

🕒 April 8

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INSIGHTEC

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🔬 Science

💰 $100M Debt Financing on 2022-08

Healthcare • Pharmaceuticals • Science

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

• Serve as US Agent and Official Correspondent for Insightec • Develop and lead clinical regulatory strategies for Class II and Class III medical devices from early development through market approval. • Interpret and apply complex regulatory and quality requirements to clinical trial planning and execution, and ensure submissions meet the latest regulatory requirements and are completed on schedule. • Review and submit high-quality clinical regulatory documentation, including new and subsequent supplements for IDE/IND, ITA/CTA, EU CTAs, PMAs, 510(k)s, prepare and submit clinically relevant Design/SW changes. • Ensure compliance with applicable clinical trial regulations (e.g. 21 CFR 812, ICH-GCP, MDR, ISO 14155) and quality management system requirements medical devices (e.g. 21 CFR 820, ISO 13485, ISO 14971, IEC, etc.). • Lead and prepare teams for pre-submission meetings, advisory panels, regulatory pathway submissions, and clinical related inspections (e.g. FDA BIMO Inspections).

🎯 Requirements

• Bachelor's degree in life science or related field required; advanced degree preferred. • 8-10 years of clinical regulatory affairs experience in the medical device industry, with at least 5 years in a leadership capacity. • Deep knowledge and hands-on experience with Class III medical devices, including IDE/IND, ITA/CTA, EU CTAs, PMAs, 510(k)s, and CE Mark submissions. • Proven experience interacting with FDA and other global regulatory bodies on clinical issues. • Strong understanding of clinical trial design, statistical principles, and regulatory and quality requirements for high-risk medical devices.

🏖️ Benefits

• flexible work environment • competitive perks and benefits