Risk Management SME

Job Title: Risk Management SME
Location: Mansfield, MA (Hybrid – Days onsite)

Duration: Months



Job Description

This is a Subject Matter Expert role in Risk Management within the Design Quality Assurance team. The role involves performing gap assessments, planning, organizing, executing, and reporting all usability and risk management activities through collaboration with cross functional teams. This role is responsible for support of EU MDR remediation projects of varying scope and complexity. This individual will collaborate with internal design and development, regulatory affairs, medical affairs, and manufacturing engineering partners.



Essential Duties and Responsibilities:

Perform thorough gap assessment of existing usability and risk management documentation against EU MDR requirements and relevant standards, such as ISO : and IEC -:

Provide risk management leadership, exp...