Risk Management Specialist - Medical Devices

Job Title: Product Safety Risk Management Specialist Job Summary: We are seeking a detail-oriented professional to take ownership of product safety risk management activities throughout the product lifecycle. This role is responsible for ensuring compliance with ISO 14971 and other applicable standards and regulations, maintaining Risk Management Files, and continuously monitoring product safety in the field. Key Responsibilities: Develop and maintain Risk Management Files during product development and lifecycle per ISO 14971 and relevant product-specific regulations. Monitor and report on product safety performance in the field, ensuring timely updates to risk documents. Assess process and product changes to determine their impact on existing Risk Management documentation. Evaluate post-market surveillance data (e.g., complaints, CAPA, NCRs, customer feedback) for implications on risk assessments and documentation. Required Skills & Experience: Strong knowledge of ISO 14971, FDA 21 CFR 820, EU MDR, IEC 60601-1, IEC 62304, and IEC 62366-1. Hands-on experience with risk analysis methodologies such as FMEA. Proven track record in developing and maintaining risk management deliverables. Strong interpersonal and influencing skills. Clinical knowledge is a plus. Show more Show less