Director, Quality & Regulatory Affairs

Job 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

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