Integrated Clinician

DNV

Hamburg

Vor Ort

EUR 70.000 - 110.000

Vollzeit

Vor 3 Tagen
Sei unter den ersten Bewerbenden
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Benefits dieser Stelle

Competitive compensation
DNV training program
Professional community
Challenging projects
Extensive competence network
Local social benefits

Zusammenfassung

DNV Product Assurance AS in Hamburg seeks an Internal Clinician to assess clinical data supporting the safety and performance of medical devices under MDR. The role involves preparing reports and contributing to certification.

You will plan and execute clinical evaluations, validate safety documentation, and ensure MDR compliance. A medical doctor with at least 2 years' experience and strong English communication is required.

Qualifikationen

  • Medical Doctor with clinical background and license.
  • At least 2 years of experience including direct patient care.
  • Experience in researching or assessing clinical data or trials.
  • Strong written and verbal English communication skills.

Aufgaben

  • Approve Certification Proposals for medical devices under MDR.
  • Assess and report on clinical aspects of manufacturers' technical documentation.
  • Plan and execute clinical evaluations within timelines and budget.
  • Evaluate safety and clinical performance reports for high-risk devices.
  • Review clinical Evaluation Reports for accuracy and MDR compliance.
  • Recommend certification based on reviewed documentation.
  • Communicate requirements and status to customers.
  • Perform competence reviews of clinicians.

Kenntnisse

English communication
Analytical
Reporting skills
Team player

Ausbildung

Medical Doctor

Jobbeschreibung

About Us

We 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.

About Us

We 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.

As 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.

About Life Sciences

We 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.

About The Role

DNV Product Assurance AS 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.

The role of Internal Clinician is to assess clinical data supporting safety and performance of devices.

Main Tasks In This Role Are
  • Approval of Certification Proposals for medical devices to be certified according to the MDR
  • Perform assessment and prepare reports of clinical aspects of legal manufacturers technical documentation according to the requirements given in the MDR
  • Plan and execute the assessment of clinical evaluation, within agreed timescales and economic budget
  • Evaluate and validate the summary of safety and clinical performance reports for high-risk medical devices
  • Review and approval of clinical evaluation report and other relevant clinical documentation for accuracy and compliance with the requirements in the MDR
  • Recommend for certification based on reviewed documentation
  • Communication with the customers with regards to requirements, status and clinically relevant aspects
  • Perform competence review of new and existing resources (clinicians)
What we offer
  • A competitive compensation and benefit package
  • DNV training and qualification program
  • A professional community in a prestigious technological company
  • Possibilities to work with interesting and challenging projects
  • Access to an extensive competence network
  • Social benefits as per DNV location (local conditions apply)

DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity.

About You
Position Qualifications:
  • Medical Doctor
  • At least 2 years of working experience including:
    • direct work experience in patient care
    • research experience in conducting preclinical or clinical trials or assessing clinical data
  • Strong written and verbal English communication skills
Personal Qualities
  • Strong technical skills concerning knowledge and experience with medical devices
  • Analytical approach
  • Good communication skills
  • Customer focus
  • Excellent reporting skills
  • Ability to work independently and efficiently
  • Team-oriented mindset
  • Ability to recommend on certification in complex cases

Application deadline: 18.10.26

Security 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.

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