Position: Regulatory Compliance Manager
Locations: Ukraine, Kyiv
Full-time (Hybrid work)
Esper Bionics is a pioneer engineering company focused on mechatronics, AI, and IoT technologies for Human Augmentation. On the way to implanted electronics, we upgrade the prosthetic industry, bring the next-level prosthetic devices here, and connect robotic prostheses under our platform to enhance their control and usability.
OUR FIRST PRODUCTS:
Headquartered in New York, our company has been recognized by numerous reputable publications, including:
What You Will Do:
Carry out certifications (standards, regulations), registration of devices on different markets (US, UA, EU), and work with Notified Bodies.
Interpreting and Implementing Regulations:
Stay up-to-date with industry-specific regulations and ensure that the organization understands and complies with them.
Translate complex regulatory requirements into actionable policies and procedures.
Develop and maintain compliance policies, procedures, and guidelines that align with applicable laws and regulations
Monitoring and Auditing:
Regularly monitor the organization’s operations to ensure they are in compliance with relevant laws and regulations.
Conduct internal audits and assessments to identify compliance gaps and areas for improvement.
Training and Education:
Train employees at all levels of the organization to raise awareness about compliance requirements and best practices.
Educate staff on the potential consequences of non-compliance.
Risk Assessment and Management:
Identify potential compliance risks and develop strategies to mitigate them.
Implement controls and processes to minimize the likelihood of compliance breaches.
Staying Current with Regulatory Changes:
Keep abreast of changes in regulations, industry standards, and best practices that may affect the organization’s compliance requirements.
Desirable experience and skills: