Medical Device - Integrated Clinician - Active & Non-Active Device
Sé de los primeros solicitantes.
Solo para miembros registrados
Barcelona
EUR 50.000 - 80.000
Sé de los primeros solicitantes.
Ayer
Descripción del empleo
Overview
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 SCPA
We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.
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 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:
• Performing assessment and preparing reports of clinical aspects of legal manufacturers technical documentation according to the requirements given in the Medical Device Regulation
• Evaluation of 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 Medical Device Regulation
• Recommend for certification based on reviewed documentation
• Communication with the customers with regards to requirements, status and clinically relevant aspects
• Performing competence review of new resources (clinicians)
• Plan and execute assessment of clinical data as required, within agreed timescales and economic budget
If you are interested, please submit your CV in English.
Please note that for candidates with employment history in Germany we cannot proceed to the interview stage without the following documents: Curriculum Vitae (CV); Cover- /Motivation Letter; University Diplomas & Transcripts; Reference Letter(s). All documents shall preferably be submitted in English. Please provide them at your earliest convenience to ensure a smooth and timely assessment process. Your cooperation in this matter is greatly appreciated.
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
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:
o direct work experience in patient care
o research experience in conducting preclinical or clinical trials or assessing clinical data
• Strong written and verbal English communication skills
Personal Qualities:
• Strong technical skills
• Analytical approach
• Good communication skills
• Customer focus
• Excellent reporting skills
• Ability to work independently and efficiently
• Ability to recommend on certification in complex cases
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
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:
o direct work experience in patient care
o research experience in conducting preclinical or clinical trials or assessing clinical data
• Strong written and verbal English communication skills
Personal Qualities:
• Strong technical skills
• Analytical approach
• Good communication skills
• Customer focus
• Excellent reporting skills
• Ability to work independently and efficiently
• Ability to recommend on certification in complex cases
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 SCPA
We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.
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 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:
• Performing assessment and preparing reports of clinical aspects of legal manufacturers technical documentation according to the requirements given in the Medical Device Regulation
• Evaluation of 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 Medical Device Regulation
• Recommend for certification based on reviewed documentation
• Communication with the customers with regards to requirements, status and clinically relevant aspects
• Performing competence review of new resources (clinicians)
• Plan and execute assessment of clinical data as required, within agreed timescales and economic budget
If you are interested, please submit your CV in English.
Please note that for candidates with employment history in Germany we cannot proceed to the interview stage without the following documents: Curriculum Vitae (CV); Cover- /Motivation Letter; University Diplomas & Transcripts; Reference Letter(s). All documents shall preferably be submitted in English. Please provide them at your earliest convenience to ensure a smooth and timely assessment process. Your cooperation in this matter is greatly appreciated.
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
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:
o direct work experience in patient care
o research experience in conducting preclinical or clinical trials or assessing clinical data
• Strong written and verbal English communication skills
Personal Qualities:
• Strong technical skills
• Analytical approach
• Good communication skills
• Customer focus
• Excellent reporting skills
• Ability to work independently and efficiently
• Ability to recommend on certification in complex cases
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
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:
o direct work experience in patient care
o research experience in conducting preclinical or clinical trials or assessing clinical data
• Strong written and verbal English communication skills
Personal Qualities:
• Strong technical skills
• Analytical approach
• Good communication skills
• Customer focus
• Excellent reporting skills
• Ability to work independently and efficiently
• Ability to recommend on certification in complex cases
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