Director of Quality Assurance & Regulatory

HumanTouch Surgical (continuing Human Xtensions) is a cutting-edge start-up developing multidisciplinary products in Minimally Invasive Surgery.

We seek an experienced Regulatory & Quality Assurance Director to join our team and report directly to the VP of R&D. The Director will lead our Regulatory & Quality Assurance team, managing the quality management system (QMS) and overseeing regulatory activities. Our company holds ISO 13485, MDR, and MDSAP certifications, and our products are already FDA-cleared and CE-approved.

Located in Netanya, we offer a dynamic, innovative environment where you’ll have the opportunity to make a significant impact while working alongside sharp, professional individuals who are passionate about the future of medical technology. We'd love to hear from you if you’re ready for a new challenge and eager to grow!

• Work closely alongside the company’s management team.
• Lead, manage, and implement quality and regulatory activities in developing and implementing regulatory premarket strategies and processes to gain product approvals worldwide.
• Manage the Quality assurance and RA team and be responsible for all quality and regulatory matters across the company's activities.
• Develop QMS strategies, systems, and processes to ensure that HTS’ product development, manufacturing, and post-market activities comply with the regulatory requirements.
• Collaborate with senior management and all functional groups at all enterprise levels to drive a culture of Quality by conceiving, collaborating, and supporting the implementation of specific actions, processes, and behaviors that support such a culture.
• Act as a trusted advisor and business partner in balancing risk and opportunity and advise on strategic decision-making.
• Drive the regulatory submissions in compliance with the applicable international regulatory requirements.
• Liaise directly with FDA, CE, and other regulatory agencies, including the preparation and leading agency meetings.
• Oversee and participate in the writing, reviewing, editing, and compiling of regulatory submissions and quality documentation.
• Hands-on work while providing support, mentorship, and guidance to the company
• Lead HTS’ external audits.

Bachelor’s degree in a related field.

• 7+ years of experience in the fields of Regulatory and Quality Assurance in the Medical Devices Industry.
• Minimum 3 years of management experience in Quality Assurance & Regulatory Affairs.
• Excellent knowledge of ISO 13485:2016, MDSAP, MDD, MDR.
• Experienced in regulatory submissions to FDA, CE, and MDSAP jurisdictions for class 2 or 3 products.
• English at a very high level – both written and verbal - Must (other languages - an advantage).
• Hands-on approach.
• Great attention to detail, and a result-driven approach.
• Excellent personal & communication skills, highly motivated.
• Team player.