Are you passionate about delivering state-of-the-art solutions?
Agfa HealthCare is a global leader in IT enabled clinical workflow and diagnostic imaging solutions, offering healthcare facilities a seamless flow of information and a 360º view of patient care. The company has a unique, holistic approach, enabling it to provide in-depth clinical know-how and fully integrated hospital-wide solutions.
For our office in Vienna (alternatively Bonn or Trier) we are looking for a
Quality and Regulatory Professional (m/f)
As Quality and Regulatory (QARA) Professional and member of an international QARA team you will ensure quality, regulatory compliance, and safety and efficacy of our medical devices and non-medical products. Being member of product development project teams, you control projects from QARA perspective and provide guidance. You are accountable for the implementation of regulatory procedures, sound application of risk management principles, and the creation of documentation to achieve timely regulatory clearances in your projects.
You are responsible for:
- Regulatory and process conformance for development and maintenance projects as a member of cross-functional 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
- Ensuring the adherence to the medical device risk analysis process as risk moderator of the development team
- 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 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, Medical Device Directive, and new Medical Device Regulation
- 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 language skills, French 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.
The minimum salary according to the bargaining agreement amounts to 56.084EUR, an overpayment depending on your education and experience including incentive plan is foreseen.
Interested? Then apply ! www.agfa.com