Regulatory Affairs Specialist
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.