LINK Medical is experiencing increased demand for our services within medical devices and in vitro diagnostics and therefore wants to strengthen the organization.
We are seeking highly motivated team players to join our team of medical device experts. You will work with a broad portifolio of customers and technologies in all phases of development. As a consultant in LINK you will deliver high quality services in accordance with our customer expectations. You will have the opportunity to develop your competence according to our customer needs and participate in activities related to business development.
- Natural science degree at college/university level
- Knowledge and experience in regulatory affairs within medical devices / in vitrodiagnostics
- Experience from development and production of medical-technical products
- Practical experience in conducting quality audits
- Experience from clinical studies and assessments of usability
- Experience of project work is an advantage
- Generally good IT skills and use of standard office tools
- Service minded with good cooperation and communication skills, as well as oral and written presentation skills in one of the
- Scandinavian languages, English and preferably German
- Independent, flexible, accurate and solution oriented
- Guide clients in implementation of quality systems according to ISO 13485 and FDA 21 CFR Part 820 (QSR) and conduct internal audits
- Participate in the development of regulatory strategies and development plans
- Participate in the planning and execution of clinical investigations/usability test.
- Supervise and prepare documentation in accordance with European (CE marking, MDR / MDD / IVDR) and US (FDA 510K / PMA) requirements for medical devices
- Guide clients in processes with Design Control and risk management for medical
- devices in accordance with international standards
- Prepare and revise Technical file / Design Dossier Documentation
- Develop clinical evaluation reports
- Development, planning, participation and reporting in projects
- Contribute to the development of LINK Medical’s business for regulatory services within medical devices and in vitro diagnostics
- Customer contact, communication with customers in projects and contribute to further develop the company in collaboration with LINK Medical’s other employees
LINK Medical offer:
LINK Medical offers an exciting and challenging position in a European CRO that has a strong local presence. The company focus on collaboration, sharing of experience and continuous development of our employees. You will be given meaningful tasks requiring a good collaboration between industry, clinical and scientific teams and the authorities. We offer a competitive salary, pension and insurance scheme and a bonus scheme for all employees.
Please send application and CV before 15 April 2019
All applications are treated confidentially. The position is preferably located in Oslo.