Software Compliance Manager (f/m/d) Product Security

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Olympus Surgical Technologies Europe

Software Compliance Manager (f/m/d) Product Securi...

Olympus Surgical Technologies Europe
Hamburg
Vor Ort
Vollzeit

Olympus is passionate about creating customer-driven solutions for the medical, life sciences and industrial equipment industries. For more than 100 years, Olympus has focused on making people’s lives healthier, safer and more fulfilling by helping to detect, prevent and treat disease, furthering scientific research and ensuring public safety. Olympus is headquartered in Tokyo, Japan, with more than 35,000 employees worldwide in nearly 40 countries. Olympus Europa, headquartered in Hamburg, Germany, serves the EMEA (Europe, Middle East & Africa) region and employs 7,500 people across 31 subsidiaries.

As high-tech specialist within the Olympus Corporation, Olympus Surgical Technologies Europe is the development and manufacturing center for endoscopy, bipolar high-frequency surgery, systems integration and reprocessing. With a total workforce of 1,800 employees in Hamburg and further locations in Teltow (Berlin), Prerov (Czech Republic) and Cardiff (Wales), the company stands for outstanding performance in medical diagnostic and therapy and offers the full range of most modern endoscopy applications from single products to procedure-oriented systems solutions. Apply now!

Your Responsibilities

  • Collaborate in the area of product security, i.e. cyber security and data protection, in connection with Olympus products
  • Determine existing legal and regulatory requirements for the development and use of software in medical devices, in particular for the area of product security
  • Interpret these requirements and ensure compliance of Olympus products and procedures by defining or adapting respective processes and work instructions
  • Continuously monitor changes in standards and newly adopted regulatory requirements in relevant information sources and committees (e.g. standardization committees)
  • Communicate the relevant regulatory requirements within the company and train employees

Your Qualifications

  • University degree in Computer Science, Data Processing, Law, Medical Technology or comparable qualification
  • Several years of experience in working with software norms and standards, ideally in the field of medical technology
  • Experience with cyber security and data protection desirable
  • Experience in medical technology advantageous
  • Understanding of the relevance and application of regulatory requirements in the medical field
  • Very good written and spoken English
  • Strong communication and assertiveness skills to demand compliant actions and appropriate documentation
  • Willingness to take on administrative tasks

Your Benefits

  • Occupational Pension
  • Canteen (discounted)
  • Christmas Bonus & Holiday Pay
  • Flexible Working Time 
  • Sport Activities
Informationen
Ort
Olympus Surgical Technologies Europe
Hamburg
Ihr:e Ansprechpartner:in

Reference Number: 80010857-22122020

www.olympus-oste.eu
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