Insulet Corporation · 1 month ago
Director Clinical Evaluation and Excellence (Remote)
United States
Full-time
Remote
Director/Executive
$183K/yr - $275K/yr
10+ years expInsulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions. The Director of Clinical Evaluation and Excellence will provide strategic oversight of clinical research studies globally, ensuring regulatory compliance and leading global regulatory submissions and safety reporting.
Health CareMedicalMedical Device
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
Qualification
Required
Bachelor's degree in Life Sciences or related field
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
Preferred
Advanced degree
RAC certification
Benefits
Medical, dental, and vision insurance
401(k) with company match
Paid time off (PTO)
And additional employee wellness programs
Company
Insulet Corporation
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.
1001-5000 employees
H1B Sponsorship
Insulet Corporation has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (58)
2024 (43)
2023 (19)
2022 (33)
2021 (41)
2020 (17)
Funding
Current Stage
Public CompanyTotal Funding
$629.5MKey Investors
DeerfieldOrbiMedAlta Partners
2025-03-18Post Ipo Debt· $450M
2009-03-16Post Ipo Debt· $60M
2007-05-15IPO
Leadership Team
Ashley McEvoy
President & Chief Executive Officer
Ana Maria Chadwick
Chief Financial Officer
Recent News
2025-12-20
2025-12-17
Company data provided by crunchbase