Regulatory Affairs Manager

3 days ago

Yoqneam Illit North District, Israel Radix Engineering Full time ₪90,000 - ₪120,000 per year

We are searching for the best talent for a Regulatory Affairs Manager role, to join our team located in Yokneam, Israel.

Purpose:
In this role, you will oversee the management and execution of regulatory strategies and procedures to ensure the release of our products in compliance with regulatory requirements and standards.

You Will Be Responsible For

  • Develop and submit regulatory documents to relevant institutions, including the FDA, EU NB's, NMPA, CFDA and other regulatory bodies worldwide.
  • Manage negotiations and communication with regulators to ensure swift approval of products.
  • Provide guidance and training to the R&D and marketing teams regarding regulatory requirements.
  • Lead a team of employees, providing feedback on performance while fostering a healthy and safe work environment.
  • Establish policies and standards for new products to ensure global regulatory compliance.
  • Partner with Clinical Operations to ensure adherence to regulations during clinical trials.
  • Oversee the development of US IDE, 510(k), and PMA submissions for medical devices.
  • Communicate business-related issues to management and ensure compliance with health and safety practices.

Qualifications And Requirements

  • Bachelor's degree in Physical or Biological Science or related field of study. A master's degree is an advantage.
  • 3-5 years of experience in all aspects of Regulatory Affairs, Quality Assurance or related field.
  • Proven experience in the Medical Device Industry.
  • 1-2 year of management experience, including the ability to manage multiple priorities, excellent problem-solving skills, and the capacity to make difficult decisions.
  • Extensive hands-on experience in activities such as product approval applications, crisis management such as product recalls, FDA inspections.
  • Strong understanding of Medical Device regulations / standards and Quality principles.

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