Risk Manager Medical Devices (m/f/d)

Job Description:

The medical technology company KARL STORZ was founded in 1945 in Tuttlingen, Germany, and is one of the internationally leading providers in the world of endoscopy. As a family business in its third generation, we employ 9,400 people worldwide in more than 40 countries – 3,400 employees are located in the Tuttlingen region alone. Our portfolio includes around 13,000 products for human and veterinary medicine. KARL STORZ stands for visionary design, precision craftsmanship, and clinical effectiveness.

Get to know us and become part of the team as

Area of Responsibility: Patient Health & Regulatory Affairs
Location: Tuttlingen, BW, DE, 78532
Work Flexibility: hybrid
Job ID: 5668

Your Mission

• Shape patient safety holistically: Ensure the safety and performance of our medical devices throughout the entire product lifecycle and continuously develop corresponding strategies.
• Actively manage risks: Identify, assess, and monitor risks in accordance with ISO 14971 and drive structured, sustainable risk management forward.
• Ensure regulatory compliance: Guarantee compliance with international regulations and ensure that new requirements are identified and implemented at an early stage.
• Set strategic impulses: Further develop risk management processes and create added value for patient safety and product quality.
• Advise stakeholders: Support internal specialist departments in decision-making processes – particularly regarding risk minimization and damage limitation measures.
• Create transparency: Clearly communicate risks, opportunities, and relevant developments to management and interface partners.
• Be responsible for documentation and reviews: Support the creation of management reviews and maintain risk management files in a structured and reliable manner.
• Drive change: Accompany projects and product adaptations within the scope of regulatory and clinical requirements and actively contribute to improvement initiatives.

Your Talents

• Successfully completed studies in Medical Technology, Natural Sciences, or Engineering, or a comparable qualification
• Successful experience in a comparable position, ideally in the regulated environment of medical technology
• Good understanding of relevant regulatory requirements and standards, especially in the area of risk management according to ISO 14971
• Ideally, knowledge in the areas of IEC 60601-1 and IEC 80002-1
• Analytical thinking as well as a structured and solution-oriented approach to work
• Strong communication skills and the ability to convey complex issues understandably
• High degree of responsibility, independence, flexibility, and teamwork skills
• Very good German and English language skills

Your Benefits

• Flexible working hours & mobile working: In many areas, working hours and location can be arranged as needed.
• 30 vacation days as well as various special payments.
• Further training opportunities: Open in-house seminar program, extensive e-learning offer, specialized further training, etc.
• Corporate Benefits advantage offers and bicycle leasing.
• Subsidy for private pension provision and company health management.
• Various childcare options – at the headquarters in Tuttlingen.
• Health, sports, culture, and leisure activities – these vary depending on the location.

Contact:

We look forward to receiving your comprehensive online application.

Further information about KARL STORZ as an employer can be found on our career page.

Carsten Engel | Recruiter Talent Acquisition
[email protected]

KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Str. 34
78532 Tuttlingen