Director, Clinical Affairs - Medical Device Strategy

Spryte Medical, LLC.; Bedford (MA); On-site; USD 215,000 - 230,000; Full time

Benefits offered by this job

Competitive compensation

Job summary

Spryte Medical in Bedford, MA seeks an experienced Director, Clinical Affairs to lead clinical research strategy and operations for regulatory submissions and post‑market evidence generation.

You will build and lead the Clinical Affairs function, manage multicenter trials, oversee CROs, and ensure ICH‑GCP and ISO 14155 compliance while partnering with Regulatory, QA, R&D, and Medical Affairs to deliver high‑quality clinical evidence.

Qualifications

• Minimum 10 years in clinical research and operations in medical device industry.
• Minimum 3 years of leadership experience managing clinical personnel or CROs.
• Proven ability to lead multicenter clinical studies from design to closeout.

Responsibilities

• Provide strategic leadership for clinical programs aligned with development and regulatory goals.
• Oversee planning, execution, and delivery of clinical investigations and reports.
• Manage site/vendor relationships and budgets to ensure timelines.
• Ensure TMF completeness and inspection readiness, with regulatory support.

Skills

ICH-GCP

ISO 14155

FDA regulations

Clinical operations

Project management

CRO management

Education

Bachelor's degree in Life Sciences

Master's degree (preferred)

Job description

Spryte Medical in Bedford, MA seeks an experienced Director, Clinical Affairs to lead clinical research strategy and operations for regulatory submissions and post‑market evidence generation.

You will build and lead the Clinical Affairs function, manage multicenter trials, oversee CROs, and ensure ICH‑GCP and ISO 14155 compliance while partnering with Regulatory, QA, R&D, and Medical Affairs to deliver high‑quality clinical evidence.