Senior Medical Safety Manager HPM (all genders)
$103,510–$138,014 year
HybridBöblingen, Baden-Wurttemberg, Germany
Job Summary
Support patient safety and regulatory compliance across the Hospital Patient Monitoring Portfolio by ensuring accurate adverse event reporting, analyzing safety data from clinical and post-market sources, and identifying emerging risks. Conduct scientific literature reviews, prepare regulatory submissions including Risk-Benefit Analyses and Clinical Study Reports, and collaborate cross-functionally to implement effective risk management strategies. Respond to inquiries from healthcare professionals and maintain up-to-date knowledge of evolving medical device safety regulations. This role requires a Bachelor's or Master's degree in Medical Science or Nursing, 7-10 years of experience in Medical or Clinical Affairs, and ICU or telemetry clinical experience. On-site attendance is at least three days weekly with 10–25% international travel. Base salary ranges from €103,510.62 to €138,014.16 with a 5% performance-linked bonus.
Required Qualifications
- Bachelor's or Master's degree in Medical Science, Nursing, Clinical Science, or an equivalent discipline
- 7-10 years of experience in Medical or Clinical Affairs within the Medical Devices or Biotech industry
- Clinical experience in adult or pediatric ICU, operating room, or telemetry environments
- Willingness and ability to travel internationally approximately 10–25% annually for internal and external meetings
- For this role this means to be on-site at least 3 days a week
- Regulatory Compliance
- Risk Management and Risk‐Benefit Analysis
- Safety Assessment & Surveillance
- Adverse Event Reporting and Signal Detection
- Safety Data Analysis and Interpretation
- Documentation and Regulatory Reporting
- Scientific Literature Review
- Strong business and stakeholder communication skills
Desired Qualifications
- Certified Professional in Patient Safety (CPPS)
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