Director Clinical Evaluation and Excellence (Remote)

Position Overview

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.

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.
  
  

Education And Experience

• 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.
  
  

Skills/Competencies

• 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.
• RAC certification preferred.
  
  

NOTE: This position is eligible for 100% remote working arrangements (may work from home/virtually 100%; may also work hybrid on-site/virtual as desired).

Additional Information

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $183,225.00 - $274,837.50 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including:

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.
  
  

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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