Director of Clinical Evaluation and Excellence

Position: Director of Clinical Evaluation & Excellence

Location: Acton, MA

Employment Type: Full-Time

About the Role:

The Director of Clinical Evaluation & Excellence leads global clinical research strategy, ensuring compliance with FDA, EU MDR, ISO 13485, ISO 14155, and GCP standards. You will oversee clinical evaluations, safety reporting, and regulatory submissions, while guiding cross-functional teams and maintaining inspection readiness.

Key Responsibilities:

• Lead global clinical development strategies aligned with regulatory and business objectives.
• Oversee clinical studies (feasibility, pivotal, and post-market) from design through reporting.
• Drive development of CERs, CEPs, PMCF plans/reports, and clinical study reports.
• Ensure compliance with global regulatory standards and evolving requirements.
• Manage regulatory submissions, IRB/EC interactions, and response strategies.
• Lead safety reporting, adverse event management, and device deficiency processes.
• Conduct gap analyses, internal audits, CAPAs, and inspection readiness activities.
• Mentor and lead a multidisciplinary team across clinical, regulatory, quality, and medical writing.
• Promote a culture of compliance, collaboration, and continuous improvement.

Qualifications:

• Bachelor's degree in Life Sciences (advanced degree preferred).
• 10+ years of experience in clinical research, regulatory affairs, or quality within medical devices.
• Expertise in global regulatory strategy, clinical documentation, and submissions.
• Strong knowledge of FDA, EU MDR, ISO standards, and GCP.
• Excellent leadership, communication, and project management skills.
• RAC certification preferred.

Employee Benefits

• Medical, dental, vision, and pet insurance
• 401(k) Retirement Savings Plans
• Employee Assistance Program (EAP)
• Commuter/Parking Accounts
• People Perks
• Health Savings Account (HSA)
• AD & D Insurance

If you are a proven leader ready to drive clinical and regulatory excellence on a global scale,

Click "Apply Now" to take the next step in your career.

Advantage Technical connects top- talent in technology, engineering, and technical fields with forward-looking companies.

Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.