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.

This role is to fill in for 4 months for a Clients’ Manager who is going on a Maternity leave. Minimum of 5 years of relevant experience Proven experience with regulatory submissions, including IND and CTAs Strong background in reviewing and editing regulatory affairs documents At least a Bachelor’s degree (with a heavy emphasis on hands-on experience) Additionally, the position will involve a panel interview as part of the selection process We are seeking a Manager, Global Regulatory Affairs, to work closely with the Global Regulatory Lead (GRL) for a given program(s).