Director Clinical Evaluation and Excellence (Remote)

Insulet Corporation•San Diego, MA

1d•Remote

About The Position

The Director of Clinical Evaluation and Excellence will provide strategic oversight of clinical research studies globally to ensure regulatory compliance. This role is pivotal in leading global regulatory submissions and safety reporting across pre-market and post-market clinical research studies. This role will also oversee the development of documents to meet EU MDR requirements including clinical evaluation reports and post-market clinical follow up 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 in Clinical Affairs.

Requirements

Bachelor’s degree in Life Sciences or related field (advanced degree preferred).
Minimum 10 years of experience in clinical research, regulatory affairs, and quality assurance within the medical device industry.
Proven leadership in global regulatory strategy and clinical documentation.
Excellent communication, leadership, and project management skills.
Excellent written and effective verbal communication skills.
Ability to communicate cross-functionally across the organization.
PC skills; word processing, spreadsheet, database, Internet search and utilization.
Flexible and able to work in a fast paced environment.
Team player.
Ability to organize and judge priorities.
Excellent ability to generate and maintain accurate records.
Deep knowledge of FDA, EU MDR, ISO 13485, ISO 14155, ICH GCP, and country-specific regulations.
Strong analytical, organizational, and communication skills.
Proficiency in MS Office Suite and clinical documentation platforms.

Nice To Haves

RAC certification preferred.

Responsibilities

Lead clinical development strategies to align with corporate and regulatory goals.
Oversee design, execution, and reporting of clinical trials (feasibility, pivotal, post-market).
Develop an in-depth understanding of global regulatory and reporting requirements and ensure compliance with ISO 14155, FDA, EU MDR, and other global standards and regulations.
Serve as clinical subject matter expert in regulatory interactions and cross-functional forums.
Prepare and submit documentation to regulatory authorities and IRB/EC.
Respond to regulatory inquiries and lead cross-functional alignment on response strategies.
Conduct gap analyses and implement procedural updates based on evolving regulations.
Oversee reporting for adverse events, protocol deviations, clinical complaints and device deficiencies, and manage safety committees.
Ensure timely and 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/reports, and clinical study reports.
Ensure 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.