Risk Manager

This is a fully remote position, open to applicants in Poland.

📋 Description

• Oversee and coordinate all risk management functions in compliance with ISO 14971, ISO 13485, MDR, and annex XVI.

• Strategize, prepare, and execute risk management for medical devices and aesthetic products throughout project phases, adhering to all relevant internal procedures, processes, and external requirements for development products.

• Act as the representative for Risk Management on designated development projects.

• Define risk acceptance criteria for individual residual risks as well as the overall residual risk for both specific devices in development and legacy devices.

• Maintain a close connection with the Human Factors / Usability Engineering process to address the needs and safety of all users and patients.

• Assist in the creation of device design specifications to ensure that risk control measures are suitable.

• Oversee the implementation, verification, and validation of risk control measures.

• Stay informed about current Company policies, standards, guidelines, industry practices, regulatory requirements, and other pertinent information.

• Promote harmonized approaches to risk management across different projects. Collaborate with Research and Development team members on various projects to share insights and ensure the utilization of common tools and ideas within the team.

• Ensure that the risk management process integrates all relevant information from the Design Authorities, including Design FMEAs, Security Risk Analysis, use-related risk analysis, formative human factors evaluations, and human factors validation studies.

• Guarantee that risk management reports are prepared promptly and in accordance with ISO 14971 and applicable Company SOPs and guidelines, ensuring they are suitable for inspection by notified bodies and other relevant authorities.

• Present project-specific risk management activities during regulatory body inspections and internal audits.

• Collaborate cross-functionally with other global teams, such as Global Marketing, Global Regulatory Affairs, Clinical Affairs, and Manufacturing.

• Foster a strong connection between risk management during development and the risk management of marketed products.

• Ensure identification of all hazards associated with medical devices and aesthetic products, estimation and evaluation of associated risks, and implementation of risk controls; oversee that these risk controls are applied, verified, and validated.

• Ensure compliance with Company quality and regulatory standards and applicable government regulations through independent risk management for medical devices in development.

• Conduct risk management for medical device and aesthetic projects, assisting medical device sites to ensure that risk management is executed in sufficient detail and within appropriate timelines for new device introductions and regulatory agency inspections.

• Hold overall responsibility for ensuring that medical devices and aesthetic products are designed to be safe, effective, and compliant with applicable regulations worldwide.

⛳️ Requirements

• At least 2 years of experience in the regulated medical device industry.

• Proficient knowledge of usability engineering or human factors engineering as it pertains to medical devices.

• Familiarity with various risk assessment methodologies.

• Master’s degree in Engineering in relevant fields or equivalent (Materials, Biomaterials, Chemistry, Biochemistry, Biology).

• Fluent in English.

🏝️ Benefits

• Opportunity to work within a global medical aesthetics organization.

• Engagement and professional development opportunities available.

• Diverse workload and collaborative project experiences.