Regulatory Compliance Manager (Medical Device, Class I) (вакансія неактивна)

Position: Regulatory Compliance Manager

Senior Level

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:

• Esper Hand (Medical Device, Class I) is a self-learning robotic prosthetic hand that detects muscle activity and adjusts the control to the user’s behavior patterns to perform everyday tasks In a more human-like dexterity. Esper Hand will be available in the US starting in the summer of 2022.
• Esper Control is a wearable, non-invasive brain-computer interface
• Esper Platform is a cloud-based software solution that uses machine learning algorithms to individualize the control of wearables, including the Hand.

Headquartered in New York, our company has been recognized by numerous reputable publications, including:

• TechCrunch, Mashable, Business Insider Mexico, and Medtech Innovation News.
• We were also named one of the top world techpreneurs at the 13th Healthcare Innovation World Cup, and in 2022, we received the prestigious Reddot “Best of the Best” award.
• Esper Hand was on the cover of TIME Magazine (one of THE BEST INVENTIONS OF 2022).

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.

Policy Development:

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:

• Regulatory Knowledge: In-depth understanding of medical device regulations and standards, including but not limited to FDA regulations, ISO 13485, MDR (Medical Device Regulation), and other relevant regional or international standards.
• Product Classification and Categorization: Familiarity with the classification and categorization of medical devices based on their risk levels and intended use, as per regulatory guidelines.
• Quality Management Systems (QMS): Hands-on experience in establishing and maintaining QMS compliant with ISO 13485, 21 CFR 820, or similar quality standards.
• Risk Management: Proficiency in conducting risk assessments and implementing risk management processes in accordance with ISO 14971.
• Compliance with International Standards: Knowledge of international regulatory requirements and standards relevant to medical devices.