Clinical Compliance & Regulatory Affairs Coordinator
Company Overview
Therapy Discoveries, PLLC specializes in providing occupational therapy services within the Triangle area. Our mission is to enhance the quality of life for individuals through personalized and innovative therapeutic interventions.
Job Overview
We are seeking a dedicated and detail-oriented Clinical Compliance & Regulatory Affairs Coordinator to join our team. This role is essential in ensuring that our clinical practices and product development adhere to all relevant regulations and quality standards. The ideal candidate will possess a strong understanding of FDA regulations, clinical trial processes, and compliance management, contributing to the integrity and safety of our therapeutic solutions.
Duties
• Monitor and interpret FDA regulations and guidelines to ensure organizational compliance across all clinical activities.
• Coordinate and support clinical trial activities, including documentation, reporting, and regulatory submissions.
• Develop, review, and maintain documentation related to chemistry, manufacturing, and controls (CMC) processes.
• Oversee compliance management systems to identify risks and implement corrective actions promptly.
• Collaborate with research teams to ensure adherence to quality assurance protocols during product development and testing.
• Manage project timelines related to regulatory submissions, audits, and inspections to ensure timely completion.
• Conduct internal audits of clinical practices and manufacturing processes to uphold high standards of quality assurance.
Skills
• In-depth knowledge of FDA regulations governing clinical trials and medical products.
• Strong understanding of chemistry, manufacturing & controls (CMC) processes within a regulated environment.
• Experience managing compliance programs related to clinical research activities.
• Excellent project management skills with the ability to coordinate multiple initiatives simultaneously.
• Proven research skills for interpreting complex regulatory documents and guidelines.
• Familiarity with quality 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 healthcare through rigorous compliance and innovative regulatory strategies.
Pay: $52,518.86 - $63,248.52 per year
Location:
• United States (Required)
Work Location: Remote
Apply Now
Apply Now
Therapy Discoveries, PLLC specializes in providing occupational therapy services within the Triangle area. Our mission is to enhance the quality of life for individuals through personalized and innovative therapeutic interventions.
Job Overview
We are seeking a dedicated and detail-oriented Clinical Compliance & Regulatory Affairs Coordinator to join our team. This role is essential in ensuring that our clinical practices and product development adhere to all relevant regulations and quality standards. The ideal candidate will possess a strong understanding of FDA regulations, clinical trial processes, and compliance management, contributing to the integrity and safety of our therapeutic solutions.
Duties
• Monitor and interpret FDA regulations and guidelines to ensure organizational compliance across all clinical activities.
• Coordinate and support clinical trial activities, including documentation, reporting, and regulatory submissions.
• Develop, review, and maintain documentation related to chemistry, manufacturing, and controls (CMC) processes.
• Oversee compliance management systems to identify risks and implement corrective actions promptly.
• Collaborate with research teams to ensure adherence to quality assurance protocols during product development and testing.
• Manage project timelines related to regulatory submissions, audits, and inspections to ensure timely completion.
• Conduct internal audits of clinical practices and manufacturing processes to uphold high standards of quality assurance.
Skills
• In-depth knowledge of FDA regulations governing clinical trials and medical products.
• Strong understanding of chemistry, manufacturing & controls (CMC) processes within a regulated environment.
• Experience managing compliance programs related to clinical research activities.
• Excellent project management skills with the ability to coordinate multiple initiatives simultaneously.
• Proven research skills for interpreting complex regulatory documents and guidelines.
• Familiarity with quality 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 healthcare through rigorous compliance and innovative regulatory strategies.
Pay: $52,518.86 - $63,248.52 per year
Location:
• United States (Required)
Work Location: Remote
Apply Now
Apply Now