Medical Safety Manager – Hospital Patient Monitoring

This is a fully remote position, open to applicants in United States.

📋 Description

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

• Provide insights and suggestions for Risk Management, Health Hazard Evaluations, Risk-Benefit assessments, and recall protocols.

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

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

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

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

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

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

• Provide input for safety studies and medical device vigilance throughout the product lifecycle.

• Evaluate clinical trial and post-market surveillance data to detect safety signals and trends.

⛳️ 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.

• Experience in Critical Care and/or Telemetry is mandatory.

• A background as a practicing clinician is essential.

• In-depth knowledge of pertinent medical device industry standards and regulations (ISO, IEC, etc.) is required.

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

• A Bachelor's or Master's degree in medical, Nursing, or a related field is necessary.

• Exceptional communication abilities with a talent for influencing cross-functional stakeholders using clinical knowledge and familiarity with medical device standards.

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

• Capability to meet minimum physical, cognitive, and environmental job demands with or without accommodations.

• US work authorization is required; candidates needing current or future sponsorship will not be considered.

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

🏝️ Benefits

• Generous paid time off (PTO).

• 401k plan with up to 7% matching.

• Health Savings Account (HSA) with company contributions.

• Stock purchase plan available.

• Education reimbursement options.

• Potential for annual incentive bonuses.

• Opportunity for sales commissions.

• Long-term incentives may be available.

• Company relocation benefits are not offered.