Medical Safety Manager – Image-Guided Therapy Devices

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

📋 Description

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

• Assist in Risk Management, Health Hazard Evaluations, Risk-Benefit Analyses, and recall processes.

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

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

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

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

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

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

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

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

• Operate in a field-based capacity away from the company’s main offices, typically at customer or supplier locations.

⛳️ Requirements

• Minimum of 5 years of experience with a Bachelor’s degree OR at least 3 years of experience with a Master’s degree.

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

• Clinical experience is required.

• Familiarity with Image Guided Therapy Devices is preferred.

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

• MD is preferred.

• In-depth understanding of pertinent medical device industry standards and regulations, including ISO and IEC.

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

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

• Exceptional communication skills and 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 needing current or future visa sponsorship will not be considered.

🏝️ Benefits

• Annual incentive bonus may be offered.

• Sales commission may be offered.

• Long-term incentives may be offered.

• Generous PTO.

• 401k with up to 7% match.

• HSA with company contribution.

• Stock purchase plan.

• Education reimbursement.

• Philips Total Rewards benefits program.

• Company relocation benefits will not be provided.