Seeking a highly motivated Medical Reviewer/Safety Reviewer III to support critical safety oversight activities for medical devices and combination products. This team plays a pivotal role in driving clinical risk analysis, medical review of adverse events, and continuous improvement initiatives across PPS functions.

Key Responsibilities:

Conduct in-depth medical review of Case Report Forms (CRFs), adverse event reports, and perform safety assessments.
Provide clinical input on risk/benefit analysis and ensure compliance with global medical device safety regulations (FDA, EU-MDR, etc.).
Draft PI site notifications and assist in periodic device safety reporting.
Participate in training, automation support, and continuous improvement projects.
Act as a clinical voice in cross-functional meetings, articulating safety-related positions and recommendations.
Support medical communications and may respond to off-label inquiries with appropriate documentation.
Review and QA data listings, study summaries, protocols, investigator brochures, and IND annual updates.

Qualifications:

Bachelor’s degree in Nursing (RN) or Biomedical Engineering required; advanced degree preferred.
3–4 years’ experience in the medical device industry is required.
Minimum 5 years of direct patient care experience preferred.
Strong understanding of device risk management methodologies (FMEA, risk analysis, clinical hazard lists).
Excellent critical thinking, communication, and documentation skills.
Proficient in Microsoft Office tools (Word, Excel, Outlook).

Medical Reviewer/Safety Reviewer - Nursing