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Risk Management and Usability Expert Medical Devices (m/f/d)

Date: Sep 25, 2021

Location: Dresden, SN, DE, 01277

Company: Heraeus

[title]
Risk Management and Usability Expert Medical Devices (m/f/d)
Location Dresden
Permanent 
Full Time
 

Imagine a job where you will have the opportunity to do exciting and challenging work, while collaborating with extraordinary colleagues. A company that invests in you and your career, providing the training, mentoring, development and support you need to be successful now and in the future. If you want a career without limits with a market-leading family-owned, global company where you can make an impact, then imagine an opportunity at Heraeus. Every day, our worldwide team of approximately 14,900 employees are bringing forward new ideas and solutions that are impacting and transforming everything from healthcare to renewable energy to e-mobility to high-tech and telecommunications.

 
 

The following challenges await you:

  • In this role you will coordinate, formulate, improve and maintain company policies, operating procedures and work instructions for Risk Management and usability.
  • As our site expert you will act as trainer for Risk Management and usability purposes,
  • As the Risk Management and Usability Expert you plan, provide guidance, review and approve Risk Management as well as usability documents in compliance with current regulatory standards for medical device development
  • You can identifiy and analyse risks related to the product realization, development, manufacturing and usage of medical devices, and define mitigations in cooperation with the developers and stakeholders involved
  • Administration and enforcement of CAPA(s) related to the fields of Risk Management and Usability; Participate and act as responsible person for the areas mentioned above in internal and external audits
  • Monitoring of proposed and current US and EU regulations and guidance related to Risk Management and Usability for medical devices and advises on the impact of such regulation


Your profile:

  • Your backround is from the medical, technical or academical area,
  • You contributed  as a professional for a minimum period of 3 years within the medical device industry
  • You gained experience with medical device regulations (CE certification in EU and FDA clearance in US) and working with a quality management system (ISO 13485); and are experienced in Design Control Procedures
  • The ability to work with different players in cross-functional teams is your natural strength,
  • Prior experience in the compilation and maintenance of Usability Files and Risk Management Files completes your profile.