Director Clinical Affairs
22 hours ago
Acton
Director of Clinical Evaluation and Excellence Location: Acton, MA 01720 Pay: Up to $148 an hour Job Type: Long Term Contract Workplace Type: Hybrid, must be willing to go to Acton, MA for meetings The Director of Clinical Evaluation and Excellence will provide strategic oversight of global clinical research studies to ensure regulatory compliance. This role is critical in leading global regulatory submissions and safety reporting across pre-market and post-market clinical research activities. The position will oversee the development of documents required to meet EU MDR requirements—including Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-Up (PMCF) reports—lead internal and external clinical audits, and support the maintenance of the quality management system. The ideal candidate will bring deep expertise in medical device regulations, clinical documentation, and cross-functional leadership to drive excellence and innovation within Clinical Affairs. Responsibilities • Lead clinical development strategies that align with corporate and regulatory objectives., • Oversee the design, execution, and reporting of clinical trials, including feasibility, pivotal, and post-market studies., • Develop a comprehensive understanding of global regulatory and reporting requirements and ensure compliance with ISO 14155, FDA regulations, EU MDR, and other international standards., • Serve as the clinical subject matter expert in regulatory interactions and cross-functional forums., • Prepare and submit required documentation to regulatory authorities and IRBs/ECs., • Respond to regulatory inquiries and lead cross-functional teams in developing response strategies., • Conduct gap analyses and implement procedural updates based on evolving regulations., • Oversee reporting of adverse events, protocol deviations, clinical complaints, and device deficiencies, and manage safety committees., • Ensure timely, accurate global safety reporting in compliance with 21 CFR 803, ISO 14155, and MDCG guidance., • Develop and maintain safety plans and investigator brochures., • Lead internal audits, CAPA processes, and inspection readiness activities., • Oversee creation of CERs, CEPs, PMCF plans and reports, and clinical study reports., • Ensure the production of high-quality documentation for regulatory submissions, publications, and technical presentations., • Manage and mentor a team of regulatory specialists, clinical writers, quality specialists, and safety professionals., • Foster a culture of compliance, collaboration, and continuous improvement., • Represent the department in strategic planning and cross-functional initiatives. Education and Experience • Bachelor’s degree in Life Sciences or a related field (advanced degree preferred)., • Minimum of 10 years of experience in clinical research, regulatory affairs, and quality assurance within the medical device industry., • Proven leadership experience in global regulatory strategy and clinical documentation., • Excellent communication, leadership, and project management skills. Skills and Competencies • Excellent written and verbal communication skills., • Ability to communicate effectively across the organization., • Strong PC skills, including word processing, spreadsheets, databases, and internet research., • Flexible and able to succeed in a fast-paced environment., • Strong team player with effective collaboration skills., • Ability to organize and prioritize work efficiently., • High attention to detail with the ability to generate and maintain accurate records., • Deep knowledge of FDA regulations, EU MDR, ISO 13485, ISO 14155, ICH-GCP, and country-specific regulatory requirements., • Strong analytical, organizational, and communication skills., • Proficiency with MS Office Suite and clinical documentation platforms., • RAC certification preferred.
Billy S.Active 11 months ago
