Clinical Affairs Consultant

$124,800 - $166,400/Yr

Comtech Telecommunications Corp. - Bothell, WA

Full-time - Senior

Bothell, WA

Telecommunications

About the position

The Clinical Affairs Consultant will play a crucial role in the development and execution of clinical evidence strategies for regulatory submissions. This position requires a strong scientific background and expertise in clinical research methodologies, particularly in the context of medical devices. The consultant will be responsible for generating evidence, conducting clinical evaluations, and ensuring compliance with regulatory standards.

Responsibilities

• Develop and execute clinical evidence strategies for regulatory submissions.
• Conduct innovative clinical trial designs and quality improvement initiatives.
• Collaborate with cross-functional partners to shape and lead projects without direct reporting authority.
• Write original scientific documents including clinical study reports and regulatory filings.
• Critically assess clinical literature and communicate findings effectively.

Requirements

• MD, PhD/MS Degree in Biomedical science or Epidemiology preferred.
• 7+ years of experience in clinical research/development/real world evidence (RWE) function, preferably in medical devices.
• Strong scientific background with expertise in evidence generation and clinical evaluation methodologies.
• Experience in Machine Learning/Artificial Intelligence algorithm clinical performance validation.
• Deep understanding of global clinical evidence requirements and applicable standards/regulations.

Nice-to-haves

• Experience in evidence evaluation and clinical evaluation (7 years preferred).
• Ability to work collaboratively in a team environment.

Benefits

• Flexible schedule