Find & Apply For Technical Writer Jobs in Portland, Maine

(6-12 month Contract ) Job Summary We are seeking a highly skilled Medical Device Reporting (MDR) Specialist to join our dynamic healthcare compliance team. In this role, you will be responsible for managing the reporting processes related to medical device adverse events, ensuring compliance with regulatory requirements, and supporting the safety monitoring of medical devices across various clinical settings. The ideal candidate will possess a strong background in clinical research, regulatory affairs, and biomedical regulatory compliance, with a focus on medical device safety and reporting standards. This position offers an opportunity to contribute to patient safety initiatives while working within a collaborative, cross-functional environment. Duties Collect, review, and analyze data related to medical device adverse events from multiple sources including hospitals, clinical trials, and healthcare providers. Prepare detailed regulatory reports in accordance with FDA regulations and international standards such as ICH GCP (International Conference on Harmonisation - Good Clinical Practice). Ensure timely submission of Medical Device Reports (MDRs) to relevant authorities, maintaining accuracy and completeness. Collaborate with clinical research teams, medical affairs, and regulatory affairs to interpret data and facilitate regulatory submissions. Maintain comprehensive documentation of adverse event reports and related correspondence for audit readiness. Monitor compliance with healthcare regulations such as JCAHO (Joint Commission on Accreditation of Healthcare Organizations) standards and health regulation policies. Conduct data analysis to identify trends or potential safety signals related to medical devices. Develop technical writing materials for research summaries, safety reports, and regulatory documentation. Support internal audits and inspections by ensuring all reporting activities adhere to pharmaceutical regulatory compliance standards. Participate in cross-functional meetings to improve data collection processes and enhance overall clinical development strategies. Requirements Bachelor's degree in biomedical sciences, healthcare administration, or a related field; advanced degrees preferred. Proven experience in clinical research methods, clinical trials, or healthcare compliance within a regulated environment. Strong knowledge of FDA regulations governing medical devices and pharmaceutical regulatory compliance. Certification such as ICH GCP certificate from a recognized issuer for CA (California) is highly desirable. Familiarity with managed care systems and hospital experience, particularly Level I or Level II trauma centers preferred. Excellent data analysis skills with proficiency in data interpretation and statistical tools. Demonstrated ability in technical writing for researchers, medical writing, and regulatory documentation. Knowledge of biomedical regulatory compliance standards including JCAHO accreditation requirements. Effective project management skills with the ability to lead teams and coordinate cross-functional activities. Strong understanding of healthcare policies related to medical device safety and health regulation policies. Exceptional attention to detail combined with excellent communication skills suitable for global audiences. If you are committed to advancing patient safety through meticulous data analysis and regulatory expertise, we encourage you to apply today. Join us in making a meaningful impact on healthcare quality worldwide.

Pay:

$39.00 - $46.00 per hour

Benefits:

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

Work Location:

In person