This role involves coordinating safety teams and managing complaints regarding Sterile Single-Use products. You'll also handle documentation, communicate with authorities, and participate in post-market safety process design.
Anforderungen
- •Degree in medical technology or engineering
- •At least 3 years in post-market safety
- •Proven experience with regulatory requirements
- •Structured and independent work style
- •Resilience and flexibility with changing requirements
- •Strong team and communication skills
- •Very good German and good English skills
Deine Aufgaben
- •Coordinate cross-functional safety teams.
- •Manage field actions for Sterile Single-Use products.
- •Review and approve reporting decisions and forms.
- •Communicate with authorities on vigilance cases.
- •Represent the company in queries about vigilance.
- •Monitor documentation for complaints and vigilance cases.
- •Serve as the contact for complaint and vigilance management.
- •Support related departments in safety management.
- •Participate in designing internal processes.
- •Represent post-market requirements in related projects.
Deine Vorteile
Flexible working hours
30 vacation days
Further training opportunities
Corporate benefits and bicycle leasing
Private pension plan subsidy
Various childcare options
Health and leisure activities
Original Beschreibung
# Post Market Safety Manager, SSU Endoscopes (m/f/d)
Job Function:
Quality Management
Location:
Tuttlingen, BW, DE, 78532
Work Location (for field-based positions):
Work Flexibility:
Hybrid
Job ID:
4435
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| **Your Mission** * You will coordinate cross-functional safety teams and independently manage field actions for Sterile Single-Use (SSU) products * You will be responsible for the technical review and approval of reporting decisions and reporting forms for vigilance cases * You will communicate with authorities regarding vigilance cases and market measures and represent the company in the event of queries * You will be responsible for monitoring the complete, consistent and timely documentation of complaint and vigilance cases as well as field actions * You will be the central point of contact for complaint and vigilance management for SSU products and will support related departments * You will actively participate in the design of internal processes and represent post-market requirements in projects related to SSU products **Your Talents** * Degree in medical technology, engineering or a comparable field * At least 3 years of experience in post-market safety, complaint and vigilance – ideally in the medical technology or pharmaceutical industry * Proven experience in dealing with regulatory requirements and authorities * Structured, independent and solution-oriented way of working * Resilience and flexibility in dealing with changing requirements * Strong team and communication skills * Very good German and good English skills |
#### Your Benefits
* Flexible working hours & mobile working: In many areas, working hours and location can be arranged as required
* 30 vacation days and various special payments
* Further training opportunities: Open in-house seminar program, extensive e-learning offering, professional development courses and much more
* Corporate benefits and bicycle leasing
* Subsidy for private pension plan and company health management
* Various childcare options – at the headquarters in Tuttlingen
* Health, sports, cultural and leisure activities – offers vary depending on location
## HR Contact
Cindy Schätzle | Junior Recruiter
Cindy.Schaetzle@karlstorz.com
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4435