( 6-12 Month Contract ) Overview We are seeking a highly skilled and detail-oriented Medical Device Reporting (MDR) Specialist to join our dynamic team. This critical role involves managing the collection, analysis, and reporting of adverse events and product complaints related to medical devices in compliance with regulatory standards. The ideal candidate will possess extensive knowledge of healthcare regulations, clinical research methods, and medical terminology, ensuring that all reports meet strict FDA and international requirements. This position offers an excellent opportunity to contribute to patient safety, regulatory compliance, and the advancement of medical device innovation. Responsibilities Collect, review, and analyze data related to adverse events and product complaints from various sources including hospitals, clinical trials, and healthcare providers. Prepare comprehensive regulatory reports in accordance with FDA regulations, ICH GCP guidelines, and other applicable health regulation policies. Ensure timely submission of Medical Device Reports (MDRs) to relevant authorities while maintaining meticulous documentation. Collaborate cross-functionally with medical affairs, regulatory affairs, clinical research teams, and quality assurance to ensure data accuracy and compliance. Interpret complex clinical data to identify trends or potential safety issues related to medical devices. Maintain up-to-date knowledge of evolving healthcare compliance standards, FDA regulations, JCAHO standards, and biomedical regulatory requirements. Support internal audits and regulatory inspections by providing detailed documentation and insights into reporting processes. Develop technical writing materials tailored for researchers and regulatory submissions that clearly communicate findings. Contribute to continuous process improvements in data collection methods and reporting workflows. Assist in training team members on MDR procedures, clinical research methods, and regulatory compliance standards. Experience Proven experience in medical device reporting within a regulated environment such as biotechnology or pharmaceutical companies. Strong understanding of FDA regulations regarding medical devices (21 CFR Part 803), health regulation policies, and biomedical regulatory compliance. Demonstrated knowledge of clinical trials, clinical development processes, and research methodologies. Experience working within hospital settings or Level I/II trauma centers is highly desirable. Excellent data analysis skills with proficiency in data interpretation tools and techniques. Background in technical writing for researchers or scientific audiences is preferred. Prior involvement in regulatory submissions, medical writing, or healthcare compliance projects. Leadership experience in project management or team coordination within a regulated healthcare setting. Familiarity with managed care systems and healthcare policy frameworks enhances overall effectiveness. Certifications such as ICH GCP or CA-specific GCP certificates are advantageous. If you are committed to advancing patient safety through meticulous data analysis and regulatory excellence, we encourage you to apply for this vital role. Join us in shaping the future of medical device safety and innovation through rigorous compliance and dedicated research.

Pay:

$39.00 - $46.00 per hour

Benefits:

401(k) Dental insurance Application Question(s): Do you have at least 3 years of medical device, IVD, or diagnostics experience? Do you have at least 2 years of post-market surveillance, complaint handling, or quality assurance experience? Have you personally supported or submitted MDRs/adverse event reports?

Work Location:

In person