Medical Safety Manager – Image-Guided Therapy Devices

Jobtailor; Deutschland; Remote; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Jobtailor is seeking an experienced Medical Affairs professional to lead safety evaluations and post‑marketing surveillance for medical devices in Germany. The role involves contributing to risk analyses, regulatory submissions, and safety reporting across clinical studies and recalls.

Ideal candidates have 5+ years in Medical/Clinical Affairs within the medical device or biotech sector, with strong knowledge of ISO/IEC standards and the ability to influence cross‑functional teams using clinical

Qualifikationen

• Experience in safety evaluations and post‑marketing surveillance within medical devices or biotech.
• Knowledge of ISO/IEC standards and regulatory requirements for medical devices.
• Proven ability to influence cross‑functional stakeholders with clinical expertise.

Aufgaben

• Conduct comprehensive evaluations of safety information from surveillance and literature.
• Provide safety inputs for regulatory submissions and risk-benefit analyses.
• Support safety perspectives for new product introductions and clinical studies.
• Identify safety signals by analyzing clinical trial and post‑market data.
• Respond to safety inquiries from healthcare professionals and patients.
• Help develop safety policies, procedures, and programs.

Kenntnisse

Safety Evaluations

Post-Marketing Surveillance

Literature Reviews

Clinical Study Reports

Data Analysis

Regulatory Submissions

Risk Management

Medical Device Vigilance

Emerging Safety Issues

Clinical Evaluation Reports

Ausbildung

Bachelor's Degree in Medical or Nursing

Master's Degree in Medical or Nursing

MD Preferred

Jobbeschreibung

• Conduct comprehensive evaluations of safety information from Post-Marketing Surveillance and literature searches
• Contribute insights and recommendations to Risk Management, Health Hazard Evaluations, Risk-Benefit analyses, and recall procedures
• Provide safety perspectives for New Product Introduction projects, clinical studies, and Post-Marketing Surveillance efforts
• Supply safety inputs for regulatory submissions, Risk-Benefit Analyses, protocols, Clinical Study Reports, and Clinical Evaluation Reports
• Conduct literature reviews and surveillance activities to identify emerging safety issues
• Respond to safety-related inquiries from healthcare professionals, patients, and internal stakeholders
• Contribute to safety-related policies, procedures, and programs
• Maintain awareness of evolving medical product safety regulations and guidelines
• Provide input into safety studies and medical device vigilance activities
• Analyze clinical-trial and post-market surveillance data to identify safety signals and trends

Requirements

• 5+ years of experience with a Bachelor's OR minimum 3+ years of experience with a Master's
• Experience in Medical/Clinical Affairs in the Medical Device/Biotech industry or equivalent
• Experience with Image Guided Therapy Devices preferred
• Experience as a clinician is required
• Bachelor's/Master's Degree in Medical, Nursing, or equivalent
• MD preferred
• Strong knowledge of relevant 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 environment
• Ability to meet minimum physical, cognitive, and environmental job requirements with or without accommodation
• Excellent communication and ability to influence cross-functional stakeholders using clinical expertise and knowledge of standard of care and medical device standards
• US work authorization required
• Candidates requiring current or future work-visa sponsorship will not be considered

Core Competencies

Demonstrates expertise in conducting safety evaluations, analyzing clinical trial data, and providing insights for risk management in the medical device industry. Proficient in regulatory submissions and maintaining compliance with evolving safety regulations.

Highest-signal resume keywords

• Medical Device Industry Standards
• Health Hazard Evaluations
• Risk-Benefit Analyses
• Clinical Affairs Experience
• Image Guided Therapy Devices

Hard Skills

• Safety Evaluations
• Post-Marketing Surveillance
• Literature Reviews
• Clinical Study Reports
• Data Analysis
• Regulatory Submissions
• Risk Management
• Medical Device Vigilance
• Emerging Safety Issues
• Clinical Evaluation Reports

Soft Skills

• Excellent Communication
• Influencing Stakeholders

Certifications & Qualifications

• Bachelor's Degree in Medical or Nursing
• Master's Degree in Medical or Nursing
• MD Preferred

Industry Keywords

• Medical Device
• Biotech
• ISO Standards
• IEC Standards
• Clinical Affairs
• Safety Signals
• Risk-Benefit Analysis
• Post-Marketing Surveillance
• Health Hazard Evaluation
• Image Guided Therapy