Regulatory Affairs Manager

Regulatory Affairs Manager

Location: Caesarea Industrial Park

A promising, dynamic, and fast-growing medical device startup is seeking a talented, experienced, and practical Regulatory Affairs Manager to lead regulatory efforts for a groundbreaking, multidisciplinary medical device heading to market. The company is part of an established group of companies specializing in medical devices, offering a fascinating role with significant future development potential. This position reports directly to the CEO and provides an opportunity to work in a dynamic, challenging, yet flexible and rewarding environment.

Key Responsibilities

Define and oversee the company's regulatory strategy, ensuring alignment with business goals.

Manage and execute pre-submissions and regulatory submissions to the FDA, as well as CE marking processes as required.

Conduct regulatory gap analyses, risk assessments, and provide actionable recommendations.

Prepare, coordinate, and execute regulatory packages, including 510(k) submissions, technical files, and other necessary filings.

Collaborate closely with R&D and clinical teams to establish and execute regulatory strategies, testing programs, V&V plans, and clinical trials, ensuring regulatory compliance throughout the product development lifecycle.

Ensure product labeling, instructions, and marketing materials comply with FDA requirements, and oversee post-market surveillance activities.

Provide training and guidance to internal teams regarding regulatory requirements and best practices.

Serve as the company's regulatory affairs representative in meetings, including pre-submissions, FDA consultations, and engagements with regulatory consultants.

Prepare to represent the company during regulatory audits and inspections.

Work closely with global team members and stakeholders to ensure effective execution of regulatory strategies.

Requirements

Bachelor’s degree in a scientific field (e.g., Engineering or Life Sciences).

Proven experience with FDA submissions, pre-submissions, audits, or similar regulatory processes.

At least 8 years of demonstrated experience in regulatory affairs within the medical device industry.

Hands-on experience with multidisciplinary medical devices that include hardware and software components.

Strong attention to detail with practical problem-solving skills and the ability to balance priorities effectively.

Proven ability to work efficiently with cross-functional teams and external partners.

Experience leading tasks and processes independently.

Knowledge and experience in research methodologies and statistical analysis.

Strong technical skills: full proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).

Excellent verbal and written communication and presentation skills, in both Hebrew and English.

Proven leadership abilities with experience mentoring junior regulatory team members.

Experience working in a multicultural environment and with diverse teams.

This role offers the chance to be a key player in bringing a cutting-edge medical device to market while working in a collaborative and supportive environment. Join us and be part of shaping the future of healthcare innovation.