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Regulatory Affairs Manager
·Israel
Not specifiedFull-timeProduct ManagementMedical Devices
Join a medical device company dedicated to advancing prostate cancer care through innovative spacing solutions. As Regulatory Affairs Manager, you will coordinate regulatory activities during product development and launch, establish regulatory strategies, and ensure compliance to obtain and maintain market approvals globally.
Responsibilities
- Facilitate development of regulatory plans for new product development projects.
- Prepare and manage US FDA medical device submissions such as Pre-Submissions and 510(k)s, and communicate with FDA reviewers.
- Prepare and maintain medical device submissions for Canadian Medical Device Licenses and EU Technical Files under Regulation (EU) 2017/745.
- Lead development of responses to regulatory authorities’ requests for additional information.
- Interface with International Submission Management to support dossier preparation for global markets including Japan, Asia Pacific, and the Middle East.
- Monitor proposed changes to worldwide regulatory requirements and advise management.
- Maintain regulatory files and tracking databases, providing reports on current, pending, and future approvals.
- Provide regulatory support to cross-functional initiatives including manufacturing, quality assurance, product development, and clinical affairs.
Requirements
- Bachelor’s degree in Science, Engineering, or a related discipline.
- Significant Regulatory Affairs experience within the medical device industry.
- Proven experience preparing and managing global regulatory submissions, including 510(k), CE Mark, and other market approvals.
- Strong track record of developing regulatory strategies and supporting products throughout their lifecycle across global markets.
- Working knowledge of key regulations and standards, including FDA, EU MDR, ISO 13485, and risk management principles.
- Excellent analytical, project management, and problem-solving skills.
- Strong written and verbal communication skills with the ability to influence and collaborate across global, cross-functional teams.
- High ethical standards, sound judgment, and a commitment to quality and compliance.
- Willingness to travel internationally on occasion.
Benefits
- Competitive salary and locally competitive benefits package.
- Company benefits supporting wellbeing, development, and work-life balance.