Job Details

Job Description: 
We are seeking a highly detail-oriented and accountable Regulatory Affairs Coordinator 3 to support key regulatory operations activities. This role requires strong organizational skills, a high degree of ownership, and the ability to quickly identify and escalate issues while maintaining close communication with assigned full-time team members. 
 

Key Responsibilities: 

• Support eIFU activities, including metadata management, completion of required forms, and timely uploads to eIFU website 

• Perform Product Information Management (PIM) entries inputting UDI, EUDAMED and other country UDI database attributes into the system 

• Execute and support end-to-end distribution-related activities for products across sustaining projects and integration efforts, including certificate lifecycle management, compliance actions such as hard stop holds, distribution control releases for applicable regions (US, EU, ROW), and distribution release closure activities, ensuring alignment with regulatory and operational requirements. 

• Maintain clear, proactive communication with internal teams to support execution and compliance 

• Other incidental duties assigned by leadership may include but not limited to:  

• • Develop and execute global regulatory strategies by collaborating closely with cross-functional teams and regulatory associates around the world 

• • Assess the regulatory impact of device modifications 

• • Develop robust non-filing justifications for the US and EU in response to product modifications 

• • Coordinate and prepare letter to files for the US and technical documentation updates for the EU in response to product modifications 

    Education: 
    Bachelor’s degree in related field or scientific discipline (e.g., Biology)

    Experience: 

    Must haves:  
    Strong attention to detail with excellent organizational, analytical, and problem-solving skills
    * Ability to manage competing priorities in a fast-paced environment
    * Effective communicator and collaborative team partner with strong interpersonal skills and ability to work cross-functionally
    * Demonstrate a strong willingness to learn new processes, tools, and technologies
    * Extensive knowledge and understanding of US FDA (Class II) and EU MDR (Class IIa/IIb/III) regulations relevant to medical devices
    * Experience with authoring EU technical documentation, supporting notify body change notifications in coordination with cross-functional teams, compile and support 510(k) activities, and product lifecycle maintenance
    * Ability to interact professionally with all organizational levels
    * Follow guidance, ask questions, and training to develop role specific skills.  

    Nice to haves:  

    • Ability to build productive internal/external working relationships 
    • Coursework, seminars, and/or other formal government and/or trade association training 
    • Knowledge and understanding of global regulatory requirements relevant to medical devices 
    • Proficiency in document management systems and Microsoft Office