For the earliest possible start date we are searching for a highly qualified

Senior Manager Quality and Regulatory (f/m/d) 

to join our expanding QM team in our Munich , Germany (DE) office.

 

Responsiblities: 
 
  • Define quality and regulatory standards and oversee all compliance and processes at Definiens across software and diagnostic solution development
  • Take strong leadership and responsibility for the corporate Quality Management and the required regulatory standards (Regulatory Affairs)
  • Take the role as Definiens “Quality Management Representative”
  • Provide quality compliance advice to Definiens leadership with a focus on the corporate quality policy and appropriate quality management system
  • Anticipate internal and/or external business and legislative issues impacting own and other areas of the business
  • Maintain Definiens RUO / G(L)CP Compliance through Standard Operation Procedures (SOPs), documents, records, forms, and work instructions
  • Lead internal and external audits projects, provide corrective action and identify process improvement to guide software / product development teams and the Definiens service organization
  • Schedule periodical (and mandatory) trainings of Definiens’ employees for the purpose of deepening their compliance awareness and unification of procedures in a G(L)CP environment
  • Manages the performance and results of individuals/teams accountable for different Jobs.    
  • Manage task of “Document Control” and approved documentation developed within Definiens
 
Qualifications and Skills:
 
  • Bachelor’s degree or higher in science or business administration
  • Minimum of 6 years experience in quality management in the healthcare, pharmaceutical or medical devices / diagnostic industry with experience in prospective trials that include the test development and requirements of predictive biomarker
  • Previous engagement and experience with regulatory authorities and responsible notified bodies
  • Extensive knowledge of the clinical diagnostic & medical device regulations and in the development and approval of medical diagnostic tests
  • Knowledge of (medical) software development and validation in the designated regulatory environment
  • Understanding the industrial and regulatory requirements (US and EU) for a Go-to-market strategy with a diagnostic test / medical device according to current standards (GCP, IVDR, GDPR etc.) 
  • Previous engagement and experience with regulatory authorities and responsible notified bodies
  • Understanding the quality framework and regulations in healthcare IT and medical software development is of advantage
  • Strong written, verbal, and interpersonal communication skills (in English), with the ability to effectively interact with people at all levels
  • Ability to work independently, showing high skill in leadership, organization and prioritization skills
 
We offer: 
 
This is a challenging and rewarding position within a pioneering company that works with cutting edge technologies. We offer a modern, creative and open minded working environment with great colleagues and team spirit in the center of Munich and excellent working conditions with ongoing professional development opportunities. Be part of our mission to improve patient’s lives.

 

For more information please visit: www.definiens.com

 

 

 

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