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Permanent position - Senior Device Development Manager (m/f) - Germany  

Anteris Medical (company)


Posted on : 08 May 2017

Project Description

Key responsibilities
  • Preparation of development, quality and regulatory documents in compliance with regulatory standards
  • Developing/compiling Technical Files and Design Dossiers
  • Management of device development projects
  • Strategic planning and preparation of regulatory submission documents, interpretation of regulations and compliance with regulatory guidance
  • Driving risk management activities during development and post-launch
  • Performing design validation activities, e.g. planning, execution and reporting of Human Factors studies
  • Consulting with customers regarding quality management and quality control challenges
  • Auditing according to EN ISO 13485 and CFR 820

Your profile
  • Bachelor / Master in engineering or life sciences or with an equivalent combination of qualification and experience
  • Knowledge of regulatory guidelines: Medical Device Directive (MDD) – Directive 93/42/EEC, CFR 820, EN ISO 13485 and EN ISO 14971,
  • Ideally with experience in the field of medical devices of at least 3 years (Master) or 5 years (Bachelor)
  • Client-focused approach to work
  • Excellent communication skills (verbally and in writing)
  • Ability to work independently, take initiative, and have a flexible approach with respect to work assignments and training needs
  • Analytic and business-oriented thinking
  • Ability to travel locally and internationally, as required
  • Ability to work at the client’s site, as required
  • Excellent command of English and German

  • Working for and being part of a fast-growing organization
  • Work with a high degree of responsibility and independence
  • Flexibility in terms of working hours and work place
  • Work on attractive and varying projects in different geographies for different clients
  • Be part of an emerging organization in the explosive growth of the Biosimilar market
  • Attractive, performance-based compensation package