Director, Regulatory Affairs and Clinical Research

We are seeking a highly motivated and experienced Director of Regulatory Affairs and Clinical Research to lead our clinical and regulatory efforts. This pivotal role will be instrumental in advancing our product pipeline through the regulatory process and executing successful clinical trials.

Key Responsibilities:

Clinical Research

• Clinical Trial Design: Lead the scientific design of clinical trial protocols across multiple indications and stages, collaborating closely with scientific, medical, and internal stakeholders.
• Clinical Trial Management: Independently manage the entire clinical trial lifecycle, from inception to completion, including scientific trial design, data analysis, and publication strategy.
• Cross-Functional Collaboration: Collaborate effectively with clinical operations and customer success teams to ensure seamless trial execution.

Regulatory Affairs

• Global Regulatory Submissions: Lead the preparation and submission of global regulatory filings for device approvals, such as CE Mark, AMAR, and FDA 510(k).
• Regulatory Compliance: Ensure ongoing compliance with international regulatory standards and guidelines, and actively participate in audits and inspections.

Qualifications:

• Experience: 5+ years of experience in clinical research and regulatory affairs, with a proven track record of leading small teams.
• Regulatory Expertise: Prior experience with regulatory submissions to major markets, including FDA, EMA, and other relevant authorities.
• Clinical Trial Leadership: Demonstrated ability to independently design, manage, and execute clinical trials from inception to completion.
• Scientific and Medical Engagement: Experience working with key opinion leaders (KOLs) in the scientific and medical community.
• Communication Skills: Excellent written and verbal communication skills in both English and Hebrew.
• Technical Proficiency: Proficiency in using various technical systems, such as instant messaging platforms and project management tools.