Location: Yokneam
Work arrangement: Hybrid
Job description
In this role, you will lead and execute regulatory strategies and procedures to ensure our products are released in full compliance with applicable regulatory requirements and standards.
Key responsibilities
- Develop and submit regulatory documentation to relevant authorities, including the FDA and additional regulatory bodies worldwide
- Lead negotiations and maintain ongoing communication with regulators to support timely product approvals
- Provide guidance and training to R&D and Marketing teams regarding regulatory requirements
- Manage a team, provide performance feedback, drive improvement, and maintain a healthy and safe work environment
Requirements
- BSc in Physical or Biological Sciences, or a related field
- At least 5 years of regulatory experience in the medical device industry
- Strong understanding of medical device regulations and quality principles
- Ability to manage multiple priorities, excellent problem-solving skills, and the ability to make tough decisions