Medical Safety Manager – Image-Guided Therapy Devices

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

📋 Description

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

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

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

• Deliver safety contributions 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 inquiries from healthcare professionals, patients, and internal stakeholders.

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

• Stay updated on the latest medical product safety regulations and guidelines.

• Contribute to safety studies and medical device vigilance efforts.

• Analyze clinical trial and post-market surveillance data to uncover 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.

• Background in Medical/Clinical Affairs within the Medical Device/Biotech sector or a similar field.

• Experience with Image Guided Therapy Devices is preferred.

• Clinical experience is mandatory.

• Bachelor's or Master's Degree in Medical, Nursing, or a related field.

• An MD degree is preferred.

• Comprehensive understanding of applicable medical device industry standards and regulations (ISO, IEC, etc.).

• Strong 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 with the ability to influence cross-functional stakeholders using clinical knowledge and understanding of medical device standards.

• Authorization to work in the US is required.

• Candidates who require current or future visa sponsorship will not be considered.

🏝️ Benefits

• Generous Paid Time Off (PTO).

• 401k plan with up to a 7% match.

• Health Savings Account (HSA) with company contribution.

• Stock purchase plan available.

• Education reimbursement offered.

• Opportunity for annual incentive bonuses.

• Sales commission may be available.

• Long-term incentives may be provided.