Director, Quality & Regulatory Affairs

Insightec•Miami, FL

22h

About The Position

Experienced and strategic Director of Quality and Regulatory Affairs leading and executing global clinical regulatory strategies for Insightec Class II and Class III medical devices, including submissions, and interactions with various regulatory authorities (e.g. FDA, Health Canada, Competent Authorities, PMDA, etc).

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.
Excellent leadership, communication, and cross-functional collaboration skills.

Nice To Haves

Experience with novel technologies or breakthrough device designation.
Familiarity with but not limited to focused ultrasound, neuromodulation, software, and medical devices together with drug for clinical investigations for blood brain barrier.
Prior experience in global regulatory strategy, especially FDA, Health Canada, EU MDR, and Asian markets.
Prior experience in quality assurance, global quality management system requirements.

Responsibilities

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).
Provide regulatory and quality guidance on clinical trial protocols, informed consent forms, investigator brochures, investigational device design, and other supporting clinical and investigational documentation.
Actively participate in internal governance, risk assessments, and go/no-go decisions related to clinical and R&D development.
Provide regulatory guidance and regulatory sponsor requirements for Investigator Initiated Trials (IIT)and expanded access studies
Participate and provide regulatory and quality guidance in the PRP meetings for marketing and promotional materials.