Integrated Clinician

2 weken geleden

Amsterdam, Gem. Amsterdam; Noord-Holland, Nederland DNV GL Voltijd

pbIntegrated Clinician /b — the role of Internal Clinician is to assess clinical data supporting safety and performance of devices. /p ul liLocations: Oslo, Norway; Praha 6, Czech Republic; Stockholm, Sweden; Espoo, Finland; Gdynia, Poland; Hamburg, Germany; Anvers, Belgium; Amsterdam, Netherlands; Arnhem, Netherlands; Barcelona, Spain; Madrid, Spain; Milano, Lombardia, Italy; Piraeus, Greece; Hellerup, Denmark; Lisboa, Portugal /li liBusiness: Life Sciences /li liPosition type: Full Time /li liContract type: Permanent Employee /li /ul h3About us /h3 pWe are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. /p pAs a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations. /p pbAbout Life Sciences /b /p pWe help our customers in medical devices, healthcare, and aquaculture/ocean industries build trust and transparency across their products, assets, and supply chains. By working with customers to certify medical technologies, support safe and sustainable healthcare practices, and advance responsible aquaculture and ocean stewardship, we help manage risks, meet regulatory demands, and achieve long‑term goals. Drawing on deep technical expertise, we partner with customers worldwide to bridge trust gaps between patients, providers, producers, and consumers—driving sustainable results and improved ESG performance. /p h3About the role /h3 pbDNV Product Assurance AS /b is one of the leading Notified Bodies for medical devices. Unit is entitled to carry out tasks related to conformity assessment of medical devices with EU Medical Devices Regulation (MDR) before such products are placed on the market. /p pbMain tasks in this role are: /b /p ul liApproval of Certification Proposals for medical devices to be certified according to the MDR /li liPerform assessment and prepare reports of clinical aspects of legal manufacturers technical documentation according to the requirements given in the MDR /li liPlan and execute the assessment of clinical evaluation, within agreed timescales and economic budget /li liEvaluate and validate the summary of safety and clinical performance reports for high-risk medical devices /li liReview and approval of clinical evaluation report and other relevant clinical documentation for accuracy and compliance with the requirements in the MDR /li liRecommend for certification based on reviewed documentation /li liCommunication with the customers with regards to requirements, status and clinically relevant aspects /li liPerform competence review of new and existing resources (clinicians) /li /ul h3About you /h3 pbPosition

Qualifications:
/b /p ul liMedical Doctor /li liAt least 2 years of working experience including: /li lidirect work experience in patient care /li liresearch experience in conducting preclinical or clinical trials or assessing clinical data /li liStrong written and verbal English communication skills /li /ul pbPersonal Qualities: /b /p ul liStrong technical skills concerning knowledge and experience with medical devices /li liAnalytical approach /li liGood communication skills /li liCustomer focus /li liExcellent reporting skills /liliAbility to work independently and efficiently /li liTeam-oriented mindset /li liAbility to recommend on certification in complex cases /li /ul h3What

we offer
/h3 ul liA competitive compensation and benefit package /li liDNV training and qualification program /li liA professional community in a prestigious technological company /li liPossibilities to work with interesting and challenging projects /li liAccess to an extensive competence network /li liSocial benefits as per DNV location (local conditions apply) /li liGlobal profit share scheme, depending on year-end results /li liTravel, life, and accident insurance /li liPension and retirement benefits /li liProfessional development through everyday tasks, projects, working with others, mentoring, and formal education /li liHybrid Working: Adapting to the changing world of work around the world. /li liOpportunities to connect through social and professional networks /li liFlexible

working hours
and workplace, annual vacation allowance, competitive pension, insurance, and a global profit share scheme /li /ul pSecurity and compliance with statutory requirements in the countries in which we operate is essential for DNV. Background checks will be conducted on all final candidates as part of the offer process, in accordance with applicable country-specific laws and practices. /p #J-18808-Ljbffr