Medical Reviewer/Safety Reviewer III

The Fountain Group; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

A leading company is seeking a healthcare professional for their Medical Device Safety team. This fully remote role requires a Bachelor's or Associate's degree with active RN licensure and entails managing device safety reporting, ensuring compliance, and supporting cross-functional initiatives to enhance patient safety. The successful candidate will leverage their healthcare expertise and clinical trial experience to deliver results in a high-impact environment.

Qualifications

• Active RN licensure required.
• Relevant background in medical device safety and regulatory compliance.
• Strong capabilities in communication and problem-solving.

Responsibilities

• Assist with medical device safety reporting and continuous improvement projects.
• Support training and conducting consultations on product safety usage.
• Manage individual and periodic safety notifications.

Skills

Data Analysis

Problem-solving

Communication

Research

Data Automation

Regulatory Guidelines Knowledge

Clinical Trial Experience

Education

Bachelor's or Associate's degree with RN

Tools

Microsoft Office

Rave EDC

Veeva EDC

Oracle

Salesforce

Job description

Pay: $45-48
This role is 100% remote
1 year to start with potential extension or permanent based on performance

Must Need: Bachelor's or Associate's degree with RN required (Active licensure)

Job Description:

• The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives.
• The team is a high-profile, high-impact team that collaborates with PPS functions on various product initiatives.
• As a team member, you will work with leaders to identify critical priorities and drive high-value projects impacting patient safety.

Activities performed under this team:

• Assisting with ongoing continuous improvement projects across departmental needs.
• Handling individual and periodic medical device safety reporting.
• Managing PI site notifications.
• Supporting training and automation efforts.
• Providing medical safety consultation on risk/benefit and proper product safety usage.
• Gaining understanding of risk management regulations, standards, and guidance for medical devices and combination products.

Experience & Skills:

• Proficient in Microsoft Office, Data Analysis, Research, Data Automation, and case processing of Device SAE/AEs, complaints, and SADE potential cases.
• Knowledge of R&D and regulatory guidelines (e.g., ICH, GCP, CFR, EU-MDR, safety reporting).
• Clinical trial experience, including device trials.
• Experience with electronic databases (e.g., Rave EDC, Veeva EDC, Oracle, Salesforce).
• Strong communication skills and ability to influence without direct authority.
• Ability to multi-task, prioritize, and maintain high-quality outputs.
• Results-oriented with strategic decision-making, negotiation, change facilitation, and conflict management skills.
• Problem-solving abilities, industry awareness, and cross-functional communication skills.

Background / Education: Relevant education level as specified above.