Regulatory Affairs Leader

IceCure Medical, an innovative and fast-growing medical device company and leader in the cryoablation market, is looking for an experienced and motivated Regulatory Affairs Lead to join our Regulatory team.

Job description and Responsibilities

• Define and monitor external standards and guidelines for the company’s activities
• Coordinate, prepare, and review regulatory submissions for domestic and international projects
• Prepare and support international submissions and international product releases (CE, FDA, etc.) in accordance with applicable SOPs
• Prepare and maintain technical files and other regulatory documentation, as necessary, to obtain and sustain product approval
• Interpret regulatory rules and rule changes to ensure that they are communicated through policies and procedures
• Accompany R&D projects
• Provide regulatory input, review, and approve projects’ inputs and outputs
• Participate in product development, as required, to ensure the product follows regulatory requirements
• Work and communicate closely with company members to assist in obtaining regulatory approvals for the company’s products
• Review product promotional materials, social media, and labeling for compliance with applicable regulations and policies.
• Write and update standard operating procedures, work instructions, or policies that support regulatory activity.

Education and Experience

• Bachelor’s degree in a relevant field
• At least 5 years experience in regulatory affairs at a medical device company
• Familiarity with global regulations and standards
• Effective communication skills both verbally and in writing
• Good analytical skills
• High ability to work independently
• Self-motivated and proactive
• Fluent in English with excellent writing skills
• Excellent computer skills, including working knowledge of Microsoft Office applications