Agfa Premarket QARA Professional (m/f) in Germany
Agfa HealthCare, a leading provider of IT enabled clinical workflow and diagnostic imaging solutions, creates the future of IT in health care: as motive force we make a stand against the challenges of a market which is fast-paced with innovative ideas, concepts, and solutions.
Today, over 750 customers in Germany, Austria, Switzerland, France, Belgium, United States, and Italy have Agfa's ORBIS installed in their facility totalling over 450,000 users. Preparations for expansion in other regions are ongoing.
For our office in Bonn (Germany) we are looking for a
Premarket QARA Professional (m/f)
As Premarket QARA Professional you will ensure quality, regulatory compliance and safety, and efficacy of our products and medical devices. Being a member of the premarket project core teams you provide guidance and define regulatory plans and strategies. You are accountable for the implementation of the premarket regulatory procedures, sound application of risk management principles, and the creation of documentation to achieve timely regulatory clearances.
You are responsible for:
Regulatory and process conformance for development and maintenance projects as a member of cross functional premarket project core teams
Definition of regulatory and product quality strategy
Creation and maintenance of key regulatory deliverables of the projects
Regulatory and CE submissions in cooperation with regional QARA organizations
As risk moderator of the development team ensuring that the medical device risk analysis process is followed
Signing off key project related documentation and milestones
Taking actions on process issues for related premarket/design control processes
Identify ongoing training needs and provide training as required
Performing internal audits and defending Agfa premarket activities during external regulatory inspections and audits
University Degree (Engineering, Computer Science or Science) or equivalent combination of education and experience
At least 3-5 years’ experience in a regulated industry – preferably medical device, pharmaceutical or related – holding a position in quality assurance, regulatory affairs, quality management, or project management
Subject matter expert in regulatory affairs with in-depth knowledge of relevant health care quality standards and requirements including ISO 13485, ISO 14971, IEC 62304, IEC 62366, and Medical Device Directive 93/42/EEC
Knowledge of ISO 20000 (IT Service Management) is a plus
Operational experience with risk management processes
Ability to analyse, understand, and interpret regulations and quality standards for a more general business audience
Self-starter attitude, strong organizational skills, and the ability to meet deadlines
Team player with excellent interpersonal, collaboration, negotiation, conflict resolution, relationship-building, and communication skills
Very good German and English verbal and written communication skills, French language is an asset
We offer a rewarding career in a field that impacts lives, the opportunity to work with a talented, committed team of individuals, training and career development programs, and a competitive compensation and benefits package.
Interested? - Then we are looking forward to receiving your online application!
Agfa HealthCare GmbH
D - 53227 Bonn, Germany