Career Opportunities

Insightec is a growing medical technology company transforming patient lives through innovative incisionless surgery.

Our culture is as unique as our people, a diverse global team, with different ideas, skills, interests, and cultural backgrounds driven by our core values – Our Patients, Integrity, Team, Quality and Innovation.

Our dedication to making a real impact on the lives of millions of people and paving the path to a bright future for healthcare, is what bonds us as a Team. We work together in a dynamic collaborative environment to deliver successfully while believing and driving a life-work balance philosophy that encourages our employees to do things that are meaningful outside of work. Every role is significant, your voice is heard, and your ideas are encouraged. We challenge and empower our people to be great at what they do while providing a flexible work environment.

Walking through our corridors, you will be inspired by stories of career journeys at Insightec. We take pride in growing internal talent and encourage our employees to achieve their professional ambitions. With employees in Israel - Haifa and K. Ono, Miami and Dallas, Shanghai, Tokyo and Europe, we offer in each region competitive perks and benefits.

Do the most meaningful work of your career by joining us on our mission to transform tomorrows, today.

Position Summary:

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).

Key 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.

Qualifications:

• 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.

Preferred Experience:

• 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.

Leadership Competencies:

• Executive presence: articulates complex regulatory, quality and business issues clearly and confidently to the VP Regulatory Affairs/Quality Assurance, and other senior leaders, regulatory authorities, and external stakeholders. 
• Strategic thinking: connects regional nuisances with global strategy; sees the full product lifecycle and regulatory and quality interdependencies from early development to commercialization.
• Influencing and stakeholder management: excels in managing cross-functional and cross-regional relationships in a matrixed organization; drives alignment without direct authority.
• Decisive leadership: makes timely, data-driven decisions in uncertain or complex regulatory and quality environments; balances regulatory and quality risk with business opportunity.