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Regulatory Affairs Specialist

Id: AT0094


  • Independent Laboratory Work and Data Analysis:

    -        Plan, execute, and oversee laboratory experiments related to medical device labeling and performance characterization.

    -        Collect accurate and reliable data, meticulously recording experimental procedures, observations, and outcomes.

    -        Perform thorough data analysis using appropriate statistical methods and software tools to derive meaningful insights.


    Design and Build Laboratory Test Fixtures:

    -        Conceptualize, design, and construct test fixtures and setups for medical device experiments, ensuring accuracy and reproducibility.

    -        Collaborate with cross-functional teams to identify specific requirements and develop tailored solutions.

    -        Troubleshoot Experiments and Instrumentation:

    -        Identify and address issues that arise during experiments, instrumentation setup, or data collection.

    -        Apply problem-solving skills to diagnose and resolve technical challenges promptly and effectively.


    Learning New Experimental Techniques:

    -        Stay current with advancements in experimental techniques, equipment, and methodologies relevant to medical device performance evaluation and labeling.

    -        Actively seeking opportunities to learn and integrate new techniques.


    Demonstration of Skill and Protocol Modification:

    -        Showcase proficiency in a diverse range of experimental techniques and adapt protocols as needed to meet specific project requirements.

    -        Collaborate with team members to optimize protocols for improved accuracy and efficiency.

    -        Scientific Context and Literature Review:

    -        Contextualize experimental findings by consulting scientific literature, citing relevant studies, and positioning your results within the broader scientific framework.

    -        Contribute to the development of comprehensive reports and presentations that effectively communicate the significance of your work.

    -        Technical Proficiency in Medical Device Performance Characterization:

    -        Apply technical expertise to assess and characterize the performance of medical devices, including functionality, safety, and reliability.

    -        Adherence to Corporate Standards and Compliance:

    -        Understand and adhere to corporate standards, code of conduct, safety protocols, medical device design controls, and relevant compliance standards (such as GxP regulations).




    This position requires a minimum of a Bachelor’s degree or its equivalent in Life Sciences or a closely related field.