Quality & Safety
Secondment via YER
Over deze vacature
Regulatory affairs specialist, for this position we have 2 openings;
- Profile 1 focused on IVDR
- Profile 2 focused on Software only but with complex clinical applications
- Responsible for developing and implementing global regulatory strategy to phase out several product lines
- Create, maintain and execute plans for phase out / phase in of the product lines in line with EU MDR and certificate changes (address and legal entity)
- Responsible for the planning, coordination and preparation of document packages for regulatory submissions for released products.
- Assure regulatory compliance throughout the full life cycle of the device, including defect and complaint reviews for program teams, provides guidance to the team on risk assessment and required corrective actions to meet regulatory requirements.
- As part of the product maintenance and development projects, perform the regulatory affairs activities
- Create an environment of positive feedback, and use professional concepts and company objectives to resolve complex issues in creative and effective ways
With a growing presence in cardiology, oncology, and women's health, Philips operates in the areas of Imaging Systems, Patient Care & Clinical Informatics, Home Healthcare and Customer Services. Philips combines its clinical expertise and human insights to create innovative solutions across the continuum of care, in partnership with clinicians and our customers, to provide better value and expand access to care for millions. Our teams are working hard every day to improve patient outcomes all the way from disease prevention and screening to diagnosis, treatment, therapy monitoring, and disease management. Irrespective of whether the care cycle takes the patient from doctor's office to hospital or hospital to home, or simply from one medical department to another, Philips Healthcare's unique medical solutions are designed to optimize the quality and flow of patient information and clinical decision making.
YER Technology offers you the possibility to join as Engineering Professional and to combine challenging assignments with extensive application and career guidance. The following conditions are applicable:
- Attractive salary according to the standards of our clients
- 25 holidays per year and the option to buy more holidays
- Good pension scheme according to STIPP
- Every hour of overtime will be compensated
- Open and transparent communication with your personal consultant
- Dutch classes
- Personal career coaching from our occupational psychologists
- Broad technical and softs skills training opportunities
- A Service Desk ready to answer all your practical questions
- The standards for the devices in scope for this role, include Software as a Medical Device (SaMD) and Hardware and Software configurable Devices, IEC 60601-1, IEC 60601-1-2, ISO 14971, IEC 62304, IEC 62366, , ISO 15223-1, and ISO 20417, IVDR/MDR. Product is targeted at sales worldwide which means medical device regulations following the QMS and in collaboration with counterparts in the target countries.
Special in above is the IVDR.
- The standards for the devices in scope for this role, include Software as a Medical Device (SaMD), ISO 14971, IEC 62304, IEC 62366, ISO 15223-1. Product is targeted at sales worldwide which means medical device regulations following the QMS and in collaboration with counterparts in the target countries.
Special in above is that this is truly Software only but with complex clinical applications.