Medical Safety Officer

Position Summary We are looking for an experienced Medical Safety Officer to support a medical device client in advancing patient safety initiatives and clinical risk oversight. This position is centered on assessing clinical safety data, identifying and evaluating potential risks, and contributing to the safe and effective use of medical technologies. The successful candidate will possess strong clinical expertise, sound medical judgment, and the ability to analyze medical evidence, support safety assessments, and collaborate across multidisciplinary teams. This is a full-time contract opportunity that includes occasional travel within the United States. Primary Responsibilities

• Lead medical safety and risk management efforts, including establishing safety performance objectives, developing clinical risk profiles, and performing benefit-risk evaluations in accordance with applicable regulatory requirements.
• Build and maintain a comprehensive clinical and medical evidence repository, including adverse event data, severity categorizations, and supporting clinical context.
• Develop and manage standardized safety coding methodologies (e.g., MedDRA, seriousness, causality, severity classifications) to support consistent evaluation, trending, and reporting of safety information.
• Collaborate with cross-functional stakeholders to monitor post-market and real-world safety data such as complaints, vigilance activities, registries, and investigations, while supporting corrective and preventive actions (CAPA/FSCA).
• Provide clinical and medical expertise for regulatory submissions, clinical evaluation reports, risk management files, and other safety-related documentation.
• Support the creation and review of product labeling content, including contraindications, warnings, and precautions, ensuring consistency with current clinical evidence.
• Assist with internal safety reviews, audits, and regulatory inspections by maintaining accurate and complete safety documentation.
• Stay informed on emerging regulatory expectations, scientific literature, and industry developments related to medical device safety and breast health technologies.
• Clearly communicate safety findings, benefit-risk conclusions, and clinical assessments to internal teams and regulatory agencies, including the FDA.

Qualifications

Education & Experience

• MD or equivalent medical degree with specialization in Radiology and/or Surgery
• Minimum of 3 years of relevant clinical experience
• Experience or demonstrated interest in medical device safety, clinical evaluation, or risk management
• Strong analytical skills with the ability to interpret clinical data and scientific literature
• Ability to work independently in a 1099 contractor capacity
• Willingness to travel domestically up to 20%

Preferred Qualifications

• Previous experience within the medical device or life sciences industry
• Familiarity with safety surveillance, risk management, or regulatory compliance activities
• Exposure to clinical research, post-market surveillance, or adverse event reporting
• Excellent communication, collaboration, and cross-functional partnership skills

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