Medical Safety Officer

• *Position Overview:** We are seeking a Medical Safety Officer with expertise in Breast Radiology and/or Breast Surgery to support a medical device client. This role focuses on evaluating clinical safety, identifying potential risks, and supporting the safe use of medical technologies. The ideal candidate will bring strong clinical knowledge and the ability to assess medical evidence, contribute to safety evaluations, and collaborate with cross-functional teams. This is a full-time contract role with some travel required across the U.S.

• *Key Responsibilities:
• Lead medical safety and risk management activities, including defining safety performance criteria, developing clinical risk profiles, and conducting benefit–risk assessments in alignment applicable regulatory standards.
• Develop and maintain a structured clinical/medical harms evidence library, including adverse event rates, severity classifications, and relevant clinical context.
• Establish and oversee standardized coding frameworks (e.g., MedDRA, seriousness, relatedness, severity) to ensure consistent classification, analysis, and trending of safety data.
• Partner with cross-functional teams to monitor real-world safety data (e.g., complaints, vigilance reports, registries) and support signal detection, investigations, and corrective actions (CAPA, FSCA).
• Provide medical input into regulatory submissions, clinical evaluation reports, risk management documentation, and safety-related materials.
• Contribute to the development and review of product labeling, including warnings, precautions, and contraindications, ensuring alignment with clinical evidence.
• Support internal safety reviews, audits, and inspections by ensuring completeness and accuracy of safety documentation.
• Monitor evolving regulatory requirements, clinical literature, and industry trends related to medical device safety and breast health technologies.
• Communicate safety assessments, benefit–risk evaluations, and key findings clearly and effectively to internal stakeholders and regulatory authorities (e.g., FDA).
• *Qualifications
• *Education
• MD (or equivalent medical degree) with specialization in:
• Radiology, and/or Surgery
• Active U.S. medical licensure
• Minimum 3+ years of relevant clinical experience
• Experience or interest in medical device safety, clinical evaluation, or risk assessment
• Strong ability to review and interpret clinical data and medical literature
• Ability to work independently in a contractor (1099) capacity
• Willingness to travel up to 20% domestically
• *Preferred Qualifications
• Prior experience working with medical devices or in a life sciences company
• Exposure to safety, risk management, or regulatory processes
• Familiarity with clinical research, post-market data, or safety reporting
• Strong communication and collaboration skills

Pay: $100.00 - $200.00 per hour Application Question(s)

• Do you have experience working with medical device safety, risk management, or clinical evaluation (e.g., safety assessments, adverse event analysis, or post-market surveillance)?
• Do you hold an MD (or equivalent) with specialization in Radiology or Surgery?
• Are you able to commit to a full-time (40 hours/week) 1099 contract role and travel within the U.S. up to 10–20%?

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