Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title: Project Manager Internal

Location(s): Washington, WA

(Remote)

Job Summary

Seeking a self-driven professional to lead and expand the impact of Medical Affairs activities related to clinical evidence planning and evaluation for medical devices used in radiation oncology. This role is responsible for developing clinical evidence strategies, supporting regulatory compliance activities, and collaborating with cross-functional stakeholders across the product lifecycle.

Key Responsibilities

• Develop and drive clinical evidence strategies for medical devices.
• Create and maintain Clinical Evaluation Plans and Reports (CEP/CER).
• Develop Post-Market Clinical Follow-Up Plans and Reports (PMCFP/PMCFR).
• Provide clinical input to cross-functional teams including:
• Clinical development
• Risk management
• Product management
• Post-market surveillance
• Execute post-market clinical follow-up activities, including:
• Customer surveys
• Annual literature reviews
• Clinical studies
• Review promotional materials and product claims for clinical accuracy and compliance.
• Support publishing of customer-facing clinical content.

Required Qualifications

• Strong understanding of Clinical Evaluation and Post-Market Clinical Follow-Up requirements for Class I-III medical devices under EU MDR.
• Master’s or PhD in one of the following:
• Medical Physics (preferred)
• Biophysics
• Biomedical Engineering
• Other related scientific disciplines with relevant experience
• 2-5 years of experience in:
• Clinical evaluations
• Medical physics
• Regulatory or related medical device fields
• Excellent technical writing and verbal communication skills.

Preferred Experience

• Familiarity with the design and manufacture of medical devices.
• Experience with radiation oncology devices or technologies.
• Ability to work independently in a remote environment.

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.