Jobs

Description

Must Have

• Ability to manage competing priorities in a fast-paced environment
• Attention to detail
• Good problem-solving, organizational, analytical and critical thinking skills
• Good written and verbal communication skills and interpersonal relationship skills
• Knowledge and understanding of global regulations relevant to medical devices (Class II and/or Class III)

Nice To Have

• Proficiency in document management systems and Microsoft Office  
• Solid knowledge and understanding of global regulatory requirements for new products or product changes.
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast-paced environment
• Demonstrate a strong willingness to learn new processes, tools, and technologies.
• Follow guidance, ask questions, and training to develop role specific skills.
• Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects
• Ability to build productive internal/external working relationships
• Coursework, seminars, and/or other formal government and/or trade association training required

JOB DESCRIPTION

• The Regulatory Affairs Coordinator III independently supports and executes regulatory activities for U.S. Class II and EU Class II & Class III medical devices across the product lifecycle.
• This role prepares and maintains regulatory submissions and technical documentation, ensures ongoing compliance with FDA and EU MDR requirements, and serves as a regulatory partner to cross-functional teams.
• This role (Coordinator III) is hybrid (remote/in-office) and works with limited supervision.

Education

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field

Experience

• 5-7 years of Regulatory Affairs experience in the medical device industry
• Direct experience supporting Class II medical devices in the U.S. and Class II and/or Class III medical devices EU
• Hands-on involvement with EU MDR technical files