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 information gathered from Post-Marketing Surveillance and literature reviews.

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

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

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

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

• Address safety-related questions from healthcare providers, patients, and internal teams.

• Assist in the development of safety-related policies, procedures, and programs.

• Stay informed about evolving medical product safety regulations and guidelines to ensure compliance.

• Provide input into the design and execution of safety studies and medical device vigilance activities.

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

• Operate with limited supervision while collaborating with cross-functional teams.

⛳️ Requirements

• Over 5 years of experience with a Bachelor’s degree OR a minimum of 3 years of experience with a Master’s degree in Medical/Clinical affairs within the Medical Device/Biotech sector or equivalent.

• Critical Care and/or Telemetry experience is mandatory.

• Practical clinical experience is required.

• Strong understanding of relevant standards and regulations pertaining to the medical device industry (ISO, IEC, etc.).

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

• Bachelor’s or master’s degree in a medical field, Nursing, or an equivalent discipline.

• MD is preferred.

• Capability to meet minimum Physical, Cognitive, and Environmental job requirements with or without accommodation.

• Exceptional communication skills and the ability to influence cross-functional stakeholders through clinical expertise and knowledge of medical device standards and standard of care.

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

• US work authorization is mandatory; candidates seeking sponsorship now or in the future will be disqualified.

• Preference for candidates in the EDT and CDT time zones.

🏝️ Benefits

• Generous Paid Time Off (PTO).

• 401k plan with up to a 7% match.

• Health Savings Account (HSA) with company contributions.

• Stock purchase plan available.

• Education reimbursement offered.

• Potential for an annual incentive bonus.

• Possible sales commission opportunities.

• Long-term incentives may be provided.