Clinical Compliance & Regulatory Affairs Coordinator

reputed company Therapy Discoveries, PLLC specializes in providing occupational therapy services reputed company the Triangle area. Our mission is to enhance the reputed company of life for individuals through personalized and innovative therapeutic interventions. Job reputed company We are seeking a dedicated and detail-oriented Clinical Compliance & Regulatory Affairs Coordinator to join reputed company. This role is essential in ensuring that our clinical practices and product development adhere to reputed company relevant regulations and reputed company standards. The ideal candidate will possess a strong understanding of FDA regulations, clinical trial processes, and compliance management, contributing to the reputed company and safety of our therapeutic solutions. Duties • Monitor and interpret FDA regulations and guidelines to ensure organizational compliance across reputed company clinical activities. • Coordinate and support clinical trial activities, including documentation, reporting, and regulatory submissions. • reputed company, review, and maintain documentation reputed company to reputed company, manufacturing, and controls (CMC) processes. • reputed company compliance management systems to identify risks and implement corrective actions promptly. • Collaborate with research teams to ensure adherence to reputed company assurance protocols during product development and testing. • Manage project timelines reputed company to regulatory submissions, audits, and inspections to ensure reputed company completion. • Conduct internal audits of clinical practices and manufacturing processes to reputed company high standards of reputed company assurance. Skills • In-depth knowledge of FDA regulations governing reputed company and medical products. • Strong understanding of reputed company, manufacturing & controls (CMC) processes reputed company a regulated environment. • Experience managing compliance programs reputed company to clinical research activities. • Excellent project management skills with the ability to coordinate multiple initiatives simultaneously. • Proven research skills for interpreting reputed company regulatory documents and guidelines. • Familiarity with reputed company assurance practices in clinical settings or manufacturing environments. • Effective communication skills for liaising with regulatory agencies, research teams, and internal stakeholders. This position offers an exciting opportunity for professionals committed to advancing reputed company through rigorous compliance and innovative regulatory strategies. Pay: $52,518.86 - $63,248.52 per year Location: • reputed company (Required) Work Location: Remote Apply tot his job Apply To this Job