Key Responsibilities:
* Risk Management Strategy:
* Develop and implement risk management processes aligned with ISO 14971 and other relevant regulatory standards.
* Ensure integration of risk management practices throughout the product development lifecycle.
* Risk Identification & Analysis:
* Perform hazard analyses, failure mode and effects analyses (FMEA), and other assessments to identify potential product risks.
* Assess risks associated with design, materials, usability, and regulatory compliance.
* Risk Mitigation & Control:
* Collaborate with cross-functional teams (engineering, quality, regulatory affairs, and clinical teams) to develop risk mitigation strategies.
* Monitor and document the effectiveness of implemented risk control measures.
* Regulatory & Compliance Oversight:
* Maintain comprehensive risk management files to support regulatory submissions and audits.
* Stay updated on evolving regulatory requirements and ensure product compliance with EU MDR, FDA, and other international regulations.
* Continuous Improvement:
* Facilitate post-market surveillance activities to identify and address emerging risks.
* Recommend improvements based on risk trends and lessons learned from internal and external sources.
* Stakeholder Communication:
* Present risk assessment findings to senior leadership and provide recommendations for decision-making.
Qualifications:
* Master’s degree in Biomedical Engineering, Mechanical Engineering, Risk Management, or a related field.
* 7+ years of experience in risk management within the medical device industry, preferably in surgical equipment or MedTech R&D.
* Strong knowledge of risk management standards, including ISO 14971 and IEC 60601.
* Familiarity with design controls, regulatory submission processes (FDA, MDR), and quality management systems (ISO 13485).
* Experience with FMEA, fault tree analysis, and other risk assessment methodologies.
* Excellent communication and project management skills in German and English