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
We are looking for an Integrated Clinician/Clinical Assessor in Medical Devices to join our Medical Technologies team in South Korea. The successful candidates will have a degree in medicine with a specialization in radiology, and 3-5 years of clinical experience, including patient care.
- The working place/country for this position will be based in South Korea at Seoul office.
NB: Foreigners with proper working VISA in Korea can apply for this position. Local conditions will apply.
Main responsibilities:
ㆍ Assessment of clinical aspects of technical documentation of
all medical devices classes according to the requirements laid down
in the
European Medical Device Regulation (MDR) and other related
regulations/standards
ㆍ Preparing list of findings in case of non-conformities with
the requirements of the MDR
ㆍ Handling of clinical evaluation consultation procedure for
certain class III and class IIb devices
ㆍ Evaluation of the Summary of safety and clinical performance
reports for implantable and class III devices
ㆍ Provide support during clinical audits of medical device
manufacturers as a clinical expert (may need a certain level of travel)
ㆍ Serving as an internal point of contact for clinical matters
as part of the interfaces with other departments, offering support of and
close
exchange with colleagues
ㆍ Support in the development of internal procedures for
clinical assessment & related subjects for yielding consistently same
results
across customers and teams
ㆍ Deliver all services within necessary timelines while
maintaining high quality
About you
Required:
ㆍ Medical doctor with a specialization in radiology or with a
specialization in dermatology with 3-5 years of clinical experience
including
patient care
ㆍ For non-physician, qualified clinical staff with national
certification in diagnostic imaging with 5-10 years of clinical experience is
required (e.g. clinical image evaluator with national qualification)
ㆍ Excellent communication skills in English (both written and
spoken)
Preferred:
ㆍ Excellent organizational and professional communication
skills
ㆍ Forward-thinking mindset and an understanding of the
Notified Body environment
ㆍ A thorough, accurate and risk based working style &
understanding the big picture while being able to dive into the detail
지원자격
