Medical Safety Manager, Hospital Patient Monitoring

This is a fully remote position, open to applicants in Alabama, +45 more states.

📋 Description

• Perform thorough assessments of safety data from Post-Marketing Surveillance and literature reviews.

• Offer insights and recommendations for Risk Management, Health Hazard Evaluations, Risk-Benefit analyses, and recall processes.

• Provide safety insights for New Product Introduction initiatives, clinical trials, and Post-Marketing Surveillance activities.

• Contribute safety information for regulatory submissions, Risk-Benefit Analyses, study protocols, Clinical Study Reports, and Clinical Evaluation Reports.

• Conduct literature reviews and surveillance tasks to detect emerging safety concerns.

• Address safety-related questions from healthcare professionals, patients, and internal stakeholders.

• Assist in developing safety-related policies, procedures, and programs.

• Keep abreast of changing medical product safety regulations and guidelines to ensure compliance.

• Provide input for safety studies and medical device vigilance initiatives.

• Analyze data from clinical trials and post-market surveillance to identify safety signals and trends.

⛳️ Requirements

• A minimum of 5 years of experience with a Bachelor’s degree, or at least 3 years with a Master’s degree.

• Experience in Medical/Clinical affairs within the Medical Device/Biotech sector or a similar field.

• Required experience in Critical Care and/or Telemetry.

• Required experience as a practicing clinician.

• Bachelor’s or Master’s degree in medicine, Nursing, or a related field.

• Strong understanding of relevant medical device industry standards and regulations, including ISO and IEC.

• Solid knowledge of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses in a medical device context.

• Capability to fulfill minimum physical, cognitive, and environmental job requirements with or without accommodation.

• Exceptional communication skills and the ability to persuade cross-functional stakeholders using clinical expertise and knowledge of care standards and medical device regulations.

• Willingness and ability to travel up to 25% based on business needs.

• US work authorization is required; candidates who need current or future work-authorized visa sponsorship will not be considered.

🏝️ Benefits

• Generous PTO.

• 401k with up to 7% match.

• HSA with company contribution.

• Stock purchase plan.

• Education reimbursement.

• Annual incentive bonus, sales commission, or long-term incentives may be offered.

• Company relocation benefits will not be provided.