Medical Safety Manager – Ultrasound

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

📋 Description

• Manage medical product safety surveillance activities independently.

• Evaluate data from post-marketing surveillance, literature reviews, clinical trials, and real-world evidence.

• Detect and evaluate potential risks and safety signals.

• Offer safety insights and recommendations for Health Hazard Evaluations, Risk-Benefit Analyses, and recall procedures.

• Assist with New Product Introduction, clinical studies, and post-marketing initiatives.

• Provide safety contributions for regulatory submissions, Risk-Benefit Analyses, protocols, Clinical Study Reports, and Clinical Evaluation Reports.

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

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

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

• Participate in safety studies and vigilance activities throughout the product lifecycle.

• Operate in a field-based position.

⛳️ Requirements

• A minimum of 5 years of experience with a bachelor’s degree, or at least 3 years of experience with a master’s degree or higher in Medical/Clinical Affairs/Medical Safety within the Medical Device industry.

• Bachelor’s or master’s degree or higher in Medical Science, Nursing, or a related field.

• Comprehensive understanding of pertinent medical device industry standards and regulations, including ISO and IEC.

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

• Prior bedside-related clinical experience is preferred.

• MD/PhD is preferred.

• Relevant specialized clinical experience is preferred.

• Certification as a Professional in Patient Safety (CPPS) is preferred.

• Exceptional communication skills with the ability to influence cross-functional stakeholders.

• Must be able to meet minimum physical, cognitive, and environmental job requirements with or without accommodation.

• US work authorization is required; visa sponsorship is not available.

• Must live in or within commuting distance to the specified locations.

🏝️ Benefits

• Generous paid time off (PTO).

• 401k plan with up to a 7% match.

• Health Savings Account (HSA) with company contribution.

• Stock purchase plan.

• Education reimbursement.

• Potential annual incentive bonus.

• Possible sales commission.

• Long-term incentives may be offered.