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Human Xtensions is an Israeli public company developing technology in the field of Minimally Invasive Surgery. We are looking for an experienced VP RA & QA, reporting directly to the CEO.
The VP of QA & RA will lead our QA & RA department and be responsible for the quality system and regulatory activities.
The company holds ISO 13485, MDR, and MDSAP certificates. The company’s products are already FDA-cleared and CE-approved.
Responsibilities
- Work closely alongside with company’s CEO and be part of the management team.
- Manage the QA and RA Department and be responsible for all quality and regulatory matters across the company activities.
- Lead, manage, and implement quality and regulatory activities in developing and implementing regulatory premarket strategies and processes to gain product approvals worldwide.
- Develop QMS strategies, systems, and processes to ensure that Human Xtensions’ product development, manufacturing, and post-market activities comply with the regulatory requirements.
- Ensure that the company’s Quality System complies with regulatory requirements and all applicable standards worldwide.
- 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.
- Develop a regulatory strategy in alignment with company’s overall commercial strategy.
- Oversee the regulatory submissions in compliance with the applicable international regulatory requirements.
- Oversee and participate in the writing, reviewing, editing, and compiling of regulatory submissions and quality documentation.
- Provide support, mentorship, and guidance to quality assurance and regulatory affairs to ensure staff can independently make sound strategic and tactical decisions.
- Lead Human Xtensions’ external audits (front room).
- Act as the Person Responsible for Regulatory Compliance (PRRC).
Requirements
- Bachelor’s degree in a related field.
- 10+ years of experience in the fields of Regulatory and Quality Assurance in the Medical Devices Industry.
- Minimum 5 years of management experience in Quality Assurance & Regulatory Affairs.
- Excellent knowledge of ISO 13485:2016, MDSAP, MDD, MDR.
- Experienced in regulatory submissions to FDA, EU, 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.
- Excellent organizational and leadership abilities.
- Team player
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