Compliance Group Inc
Job Title: Director of Clinical Evaluation and Excellence
Location:
MA Duration : 12 Months Contract : W2
Position Overview: The Director of Clinical Evaluation and Excellence will provide strategic leadership and oversight for global clinical research activities, ensuring full alignment with regulatory standards and organizational objectives. This role is central to driving global regulatory submissions and safety reporting across pre-market and post-market clinical studies. The Director will lead the development of EU MDR–compliant documentation—including Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) reports—while managing clinical audits and supporting the ongoing maintenance of the Quality Management System (QMS). The ideal candidate has deep expertise in medical device regulations, clinical documentation, and cross-functional collaboration, with a strong ability to shape and elevate clinical affairs processes across the organization.
Key Responsibilities Define and lead global clinical development strategies that support corporate and regulatory objectives. Oversee the design, execution, monitoring, and reporting of clinical trials, including feasibility, pivotal, and post-market studies. Maintain expert knowledge of global regulatory and clinical reporting requirements, ensuring compliance with ISO 14155, FDA regulations, EU MDR, and other international standards. Act as the clinical subject matter expert during regulatory interactions and cross-functional discussions. Prepare, review, and submit clinical and regulatory documentation to authorities and IRB/EC bodies. Lead cross-functional alignment and timely responses to regulatory queries. Conduct regulatory gap analyses and implement process improvements based on evolving standards. Supervise reporting and assessment of adverse events, protocol deviations, device deficiencies, clinical complaints, and safety-related issues. Ensure robust global safety reporting in accordance with 21 CFR 803, ISO 14155, and MDCG guidance. Develop and maintain safety management plans, investigator brochures, and related documentation. Lead internal clinical audits, CAPA activities, and overall inspection-readiness programs. Oversee the development and quality of CERs, CEPs, PMCF plans and reports, clinical study reports, and other regulatory deliverables. Ensure high-quality documentation for regulatory submissions, publications, and technical presentations. Lead, mentor, and support a team of regulatory specialists, clinical writers, safety professionals, and quality personnel. Promote a culture of compliance, collaboration, operational excellence, and continuous improvement. Represent Clinical Affairs in strategic planning meetings and cross-functional initiatives.
Education & Experience Bachelor’s degree in Life Sciences or a related field (advanced degree preferred). At least 10 years of experience in clinical research, regulatory affairs, or quality assurance within the medical device industry. Demonstrated success in developing global regulatory strategies and leading clinical documentation initiatives. Strong leadership, communication, and project management capabilities.
Skills & Competencies Exceptional written and verbal communication skills. Ability to collaborate effectively across departments and influence decision-making. Strong proficiency in Microsoft Office and clinical documentation systems. Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment. Demonstrated ability to maintain accurate and compliant records. Expert knowledge of FDA regulations, EU MDR, ISO 13485, ISO 14155, ICH GCP, and other country-specific guidelines. Strong analytical and organizational skills with a focus on quality and compliance. RAC certification preferred.
MA Duration : 12 Months Contract : W2
Position Overview: The Director of Clinical Evaluation and Excellence will provide strategic leadership and oversight for global clinical research activities, ensuring full alignment with regulatory standards and organizational objectives. This role is central to driving global regulatory submissions and safety reporting across pre-market and post-market clinical studies. The Director will lead the development of EU MDR–compliant documentation—including Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) reports—while managing clinical audits and supporting the ongoing maintenance of the Quality Management System (QMS). The ideal candidate has deep expertise in medical device regulations, clinical documentation, and cross-functional collaboration, with a strong ability to shape and elevate clinical affairs processes across the organization.
Key Responsibilities Define and lead global clinical development strategies that support corporate and regulatory objectives. Oversee the design, execution, monitoring, and reporting of clinical trials, including feasibility, pivotal, and post-market studies. Maintain expert knowledge of global regulatory and clinical reporting requirements, ensuring compliance with ISO 14155, FDA regulations, EU MDR, and other international standards. Act as the clinical subject matter expert during regulatory interactions and cross-functional discussions. Prepare, review, and submit clinical and regulatory documentation to authorities and IRB/EC bodies. Lead cross-functional alignment and timely responses to regulatory queries. Conduct regulatory gap analyses and implement process improvements based on evolving standards. Supervise reporting and assessment of adverse events, protocol deviations, device deficiencies, clinical complaints, and safety-related issues. Ensure robust global safety reporting in accordance with 21 CFR 803, ISO 14155, and MDCG guidance. Develop and maintain safety management plans, investigator brochures, and related documentation. Lead internal clinical audits, CAPA activities, and overall inspection-readiness programs. Oversee the development and quality of CERs, CEPs, PMCF plans and reports, clinical study reports, and other regulatory deliverables. Ensure high-quality documentation for regulatory submissions, publications, and technical presentations. Lead, mentor, and support a team of regulatory specialists, clinical writers, safety professionals, and quality personnel. Promote a culture of compliance, collaboration, operational excellence, and continuous improvement. Represent Clinical Affairs in strategic planning meetings and cross-functional initiatives.
Education & Experience Bachelor’s degree in Life Sciences or a related field (advanced degree preferred). At least 10 years of experience in clinical research, regulatory affairs, or quality assurance within the medical device industry. Demonstrated success in developing global regulatory strategies and leading clinical documentation initiatives. Strong leadership, communication, and project management capabilities.
Skills & Competencies Exceptional written and verbal communication skills. Ability to collaborate effectively across departments and influence decision-making. Strong proficiency in Microsoft Office and clinical documentation systems. Highly organized, detail-oriented, and able to manage multiple priorities in a fast-paced environment. Demonstrated ability to maintain accurate and compliant records. Expert knowledge of FDA regulations, EU MDR, ISO 13485, ISO 14155, ICH GCP, and other country-specific guidelines. Strong analytical and organizational skills with a focus on quality and compliance. RAC certification preferred.