Job Description

Job Overview: We are looking for an experienced Risk Management Owner with expertise in ISO 14971:2019 to oversee risk management processes for medical devices. This role is responsible for conducting Risk Benefit Analysis (RBA), risk assessments, and ensuring compliance with FDA and EU MDR requirements throughout the product lifecycle. Key Responsibilities: Lead risk assessments and gap analyses for medical devices, ensuring proper identification and mitigation of risks. • Conduct Risk Benefit Analysis (RBA) to evaluate trade-offs between risk and product benefits. • Ensure compliance with ISO 14971:2019, FDA, and EU MDR in risk management documentation. • Develop and maintain Risk Management Files (RMF) with clear risk assessments and control measures. • Collaborate with product development, quality, and regulatory teams to integrate risk management into the product lifecycle. • Lead risk control and mitigation strategies to ensure product safety and compliance. • Contribute to regulatory submissions by providing well-documented risk management analyses. • Continuously improve risk management processes, tools, and methodologies. Required Qualifications: 5-8 years of experience in risk management within medical devices or similarly regulated industries. • In-depth experience with ISO 14971:2019 and risk management frameworks. • Strong background in Risk Benefit Analysis (RBA) and risk documentation. • Solid understanding of FDA and EU MDR regulatory requirements. • Strong experience developing risk control strategies and maintaining risk management files. • Proven ability to work cross-functionally with development, quality, and regulatory teams. • Strong verbal and written communication skills in English. Preferred Qualifications: Relevant certifications such as Certified Risk Manager (CRM), Certified Quality Engineer (CQE). • Experience with software risk management in compliance with IEC 62304. • Familiarity with IEC 61508, ISO 14971:2020, and additional safety standards. Personal Attributes: Strong analytical and problem-solving skills, with the ability to assess complex risk scenarios. • Detail-oriented with a focus on compliance and quality. • Excellent communication skills for presenting risk assessments and mitigation strategies. • Ability to work independently and within cross-functional teams. • Capable of managing multiple projects in a fast-paced environment.