Internal Clinician

vor 2 Monaten

Hamburg, Deutschland DNV Vollzeit

Local Unit & Position Description:
DNV MEDCERT is an accredited Certification Body for ISO 13485, recognised auditing organization under MDSAP and approved Notified Body for Medical Devices Regulation. We provide global market access by certifying the safety and quality of products and systems to international safety and quality standards and regulations.

Our high professional standards and our sustainable approach guarantee you a forward-thinking work environment, within an organisation that invests in its employees, and is committed to providing you with continued development.

We are looking for an
**Internal Clinician **to join our
**DNV MEDCERT Clinical Affairs Team **in Hamburg.

The
**Internal Clinician **is responsible for the oversight of the clinical evaluation assessment of the technical documentation and is integrated in the conformity assessment process and decision making process.

**Key tasks include**:

- Work within the QM system of the company;
- Assuring regulatory compliance of the clinical evaluation assessment and scrutiny process and to improve the performance of these processes and their interaction to other processes;
- Review and scientifically challenge the clinical data contained within the clinical evaluation, and any associated clinical investigations, and appropriately guide clinical experts in the assessment of the clinical evaluation presented by the manufacturer;
- Scientifically evaluate and, if necessary, challenge the clinical evaluation presented, and the results of the clinical experts' assessment of the manufacturer's clinical evaluation;
- Ascertain the comparability and consistency of the assessments of clinical evaluations conducted by clinical experts;
- Drawing up records and reports demonstrating that the relevant conformity assessment activities in which he/she has been involved have been appropriately carried out;
- Advise the product reviewer and in particular clinical experts, on aspects of the manufacturer’s design or production processes which could be of particular relevance for the clinical evaluation and clinical aspects;
- Training of DNV MEDCERT internal and external personnel with regard to clinical requirements;
- Acquiring external Clinical Experts resource according to business needs;
- Assessing Clinical Evaluations and creating reports within the scope of a her/his Determination of Qualification;
- Support of Certification Body;
- Maintenance of the database(s) according to the requirements of the QM systems;
- Participation in Team NB / EU Commission / CORE - MD meetings.

In addition to the a.m. tasks the Internal Clinician is responsible for the following tasks, in particular:

- Relating to the assessment process of assessment of clinical evaluation and clinical aspects:

- Identify when specialist input is required for the assessment of the clinical evaluation conducted by the manufacturer and identify appropriately qualified experts including the justification of delegation of tasks;
- Responsibility in all cases where the conformity of the medical device is achieved also by clinical data. If clinical data is not deemed appropriate responsibility to examine the justification provided in order to access its adequacy;
- Assessment of the manufacturer's clinical evaluation and a clinical judgement of the opinion provided by any clinical expert and make a recommendation on the adequacy of the clinical evaluation to the certification body (decision maker);
- Drawing up records and reports on the corresponding clinical assessment activities he/she is involved including any judgement, justification and recommendation.
- Relating to the availability of personnel with relevant clinical expertise:

- Identify clinical experts;
- Appropriately train clinical experts in the relevant requirements of this Regulation, CS, guidance and harmonized standards and ensure that the clinical experts are fully aware of the context and implications of their assessment and the advice they provide.

Position Qualifications:

- Qualified as physician or comparable knowledge
- Experience with the assessment of clinical data for medical devices (or closely related products)
- Coordination skills
- Fluent in written and spoken English
- EDP knowledge
- Knowledge in EU medical devices legislation and relevant guidance documents (related to the assessment of clinical data)
- Basic knowledge of quality management

Company & Business Area Description:
DNV is the independent expert in assurance and risk management, operating in more than 100 countries. Through our broad experience and deep expertise we advance safety and sustainable performance, set industry benchmarks, and inspire and invent solutions.

We are one of the world’s leading certification, assurance and risk management providers. Whether certifying a company’s management system or products, providing training, or assessing supply chains, and digital assets, we enable customers and stakeholders to make

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