Quality Assurance Regulatory Affairs Manager

Hisense Ltd. (Babysense) is hiring!

Join our family where we do not just have jobs but a calling to do something meaningful and extraordinary.

Babysense & Hisense are developing unique, cutting-edge devices for the consumer market. Our devices are sold globally and have helped millions of babies, which provides us with a unique opportunity for consumer products with real learning insights.

Babysense is much more than a technology company. We're a brand that delivers true peace of mind to families worldwide.

We are seeking a dedicated Regulatory Affairs and Quality Assurance Manager to join our team. This role is critical in ensuring that our operations and products meet all regulatory standards.

Responsibilities:

• Identify, evaluate, and ensure compliance with all applicable laws, regulations, and standards.
• Conduct thorough reviews and ensure compliance across all target markets.
• Manage and report on medical device adverse events and corrective actions.
• Implement MDR standards within the company.
• Prepare and manage audits by regulatory authorities and certification bodies.
• Maintain direct contact with regulators and suppliers abroad.
• Lead the development and maintenance of the Quality Management System (QMS)
• Support the product development team by providing regulatory guidance and ensuring regulatory compliance throughout the product lifecycle.
• Write management reviews.
• Prepare and monitor the implementation of internal training plans.
• Conduct risk assessments.
• Handle nonconformities and complaints, and manage investigations to determine root causes and CAPA actions.

Requirements:

• A bachelor’s degree in a clinical, engineering, or scientific discipline
• At least 4 years experience in a regulatory and quality role within the medical device industry.
• Experience with regulatory and quality systems for medical devices, ISO 13485, and MDR/MDD.
• Strong analytical skills and capability of interpreting complex regulatory documents.
• High proficiency in Hebrew and English.
• Ability to work independently and as part of a team.