Purpose of function:To assure technical and dossier compliance of medical devices technical docmentation to ISO and RA regulations upon product development and/or design changes.To assure technical documentation throughout life cycle such as stability and production documentation. To assure assessment of change by QA and RA as applicable.To act as the regulatory business contact with partners distributing Trimb products.To manage international registration as part of the business development of Trimb and assure continuous growth and expanded business of Trimb.To participate in Trimb business projects to assure efficient implementation of decreased complexity of the business and increased cost savings. Function requirements: Education: - Higher education in Engineering/Natural Science and Business.Competences:- Excellent communicator; able to handle many and various types of contacts.- Good understanding and management of business relations- Good understanding of scientific and technical documentation- Excellent computer skills including experience of databases and basic desktop publishing.- Fluent verbal and written English, other languages are plus- Able to prioritise and handle a varied and sometimes heavy workload.- Work well under pressure and strict deadlines.- Project planning skills and delivery of tasks within set time lines.Experiences:- Worked in cross-functional projects concerning both commercial and technical aspects of business, ideally in Healthcare industry or similar.- Worked in an international environment within regulated industry such as medical devices, cosmetics etc.Main tasks/responsibilities/authorities:Project management & ownership: project participation and milestone deliveryDesign change to DHF for new product development as well as in change controls and update technical files.Assuring ISO compliance upon development and changeAssure RA communication of development and change for RA evaluation/submission of changeAssuring technical documentation for stability protocol and reportEnsuring appropriate production from lab scale to commercial scale including validation and qualification in close collaboration with QA team.Knowledge in MDD/MDR and ISO13485 as well as CLP.International registration by compiling of DHF of medical devices.Management of internal & external partners: effectively manages internal & external partners to ensure best-in-class communication and support for international registrations Communication: proactively communicates project status, help needed, possible delays etc. to all relevant parties and proposes solutions for any issues. Research: effectively conducts scientific research in order to address the needs of internal & external partners for commercial and technical issues.Process improvments: proposes ways to imporve the existing process.
VillkorVaraktighet och arbetstid:
Trimb Healthcare AB