Clinical Assessor for Medical Devices
Place of work: Home-Office, Warszawa, Chorzów.
WE OFFER
- Employment based on an employment contract:
- full time / permanent
- part time (optionally continuing to practise medicine part-time)
- Access to a package of employee benefits (e.g. medical care, life insurance, sports & culture card, co-financing of foreign language courses)
- Opportunity for development and professional training
- Work in a group of specialists, in a company with an established position on the market
- Friendly atmosphere
- Necessary work tools
- Possibility to work remotely
RESPONSIBILITIES
- Assessing clinical evaluations as part of technical documentation assessments according to the requirements laid down in the European Medical Device Regulation 2017/745
- Preparing reports included deficiency reports in case of non-conformities according to the requirements of the Medical Device Regulation 2017/745
- Delivering high-quality, reliable, and predictable services within defined timeframes
- Serving as an internal point of contact for TDA matters as part of the interfaces with other departments, offering support of and close exchange with colleagues
- Independent supervision of certification projects for our international customers as a project manager
- Serving as an internal point of contact for clinical matters as part of the interfaces with other departments, offering support of and close exchange with colleagues
- Readiness for intensive familiarisation with the ISO 13485, ISO 9001, MDR and MDSAP standards
- Optionally providing support during clinical audits of medical device manufacturers as a clinical expert (might require a certain level of travel)
- Supporting the development of internal position papers for certain (groups of) medical devices to ensure and maintain consistency of assessments of clinical evaluations within TÜV SÜD
- Possibility of attending medical conferences
QUALIFICATIONS
- Physician with completed medical degree
- A total of at least four years of professional experience in the field of clinical practice in health care services or related sectors including two years in usage, development or testing/evaluation of medical devices or clinical studies/investigations or clinical evaluation of medical devices
- Experience with scientific literature searches in the medical context
- Fluency in written and spoken English
- Ability to create qualified reports included deficiency reports
- Ability to work in a team, pronounced customer orientation and good self-organization
- Experience working with MS Office applications and programs
- Excellent organisational and professional communication skills
- Curiosity and willingness to learn
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