Medical Safety Manager – IGT-D
Philips
full-time
Posted on:
Location Type: Remote
Location: United States
Visit company websiteExplore more
Salary
💰 $133,000 - $237,000 per year
About the role
- Conduct comprehensive evaluations of safety information sourced from a variety of channels
- Provide essential support in bolstering patient safety
- Actively contribute insights and recommendations to critical processes
- Collaborate effectively to furnish pertinent safety inputs for regulatory submissions
- Conduct literature reviews and surveillance activities to identify emerging safety issues
- Provide answers to safety-related inquiries from healthcare professionals, patients, and internal stakeholders
- Contribute to the implementation of safety-related policies, procedures, and programs
- Maintain awareness of evolving regulations and guidelines related to medical product safety
- Analyze safety data from clinical trials and post-market surveillance to identify potential safety signals and trends
Requirements
- 5+ years of experience with Bachelor’s OR minimum 3+ years of experience with Master’s in areas such as Medical/Clinical affairs in Medical Device/Biotech industry or equivalent.
- Experience with Image Guided Therapy Devices preferred.
- Experience as a clinician is required.
- strong of relevant standards and regulations for the medical device industry (ISO, IEC, etc.).
- strong knowledge and understanding of Health Hazard Evaluations, Issue Impact Assessments, and Risk-Benefit Analyses and how to conduct them in a medical device environment.
- Bachelor’s/Master’s Degree in Medical, Nursing, or equivalent. MD preferred.
Benefits
- generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- stock purchase plan
- education reimbursement
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
safety evaluationsliterature reviewsdata analysisHealth Hazard EvaluationsIssue Impact AssessmentsRisk-Benefit Analysesregulatory submissionsclinical trialspost-market surveillanceImage Guided Therapy Devices
Soft Skills
collaborationcommunicationinsight generationproblem-solvingstakeholder engagementadaptabilityattention to detailcritical thinkingorganizational skillssupport provision
Certifications
Bachelor’s DegreeMaster’s DegreeMD