Company Description
We are SGS – the world's leading
testing, inspection and certification
company.
We are recognized as the global benchmark for
sustainability, quality and integrity .
Our 99,600 employees operate a network of
2,600 offices and laboratories , working together to enable a better, safer and more interconnected world.
Our
Innovation Factory
promotes and develops digital innovation initiatives across SGS; we deliver solutions to the business at scale and speed.
Our mission is to create a better, safer and connected world by supporting, improving or augmenting our physical operations with digital technologies.
Job Description
As an
IVDR Product Assessor , you will use your skills as an expert in
clinical diagnostic technologies
to ensure that patients across Europe have access to safe and effective diagnostic tests.
Join our rapidly growing team of regulatory professionals in helping the European healthcare ecosystem navigate the challenging transition to the new
European In Vitro Diagnostics Regulation.
Your role will be to
assess in-vitro diagnostic medical devices
for strict compliance with the relevant European laws ( EU IVDR; Regulation 2017/746 ).
Your key task will be carrying out reviews of the manufacturers'
technical documentation
as part of the
CE marking
process.
This will require a keen interest in and deep understanding of the product technologies being assessed, knowledge of the clinical application of the devices, as well as a keen eye for detail.
Key Responsibilities:
Conduct technical file reviews
against the
EU In-vitro Diagnostics Regulation
for
Class A sterile, Class B and Class C
devices within a defined timeframe, by verifying compliance of technical documentation submitted by manufacturers against the regulatory requirements.
Identify, document and seek to rectify instances where device technical files deviate from compliance with applicable requirements under the
IVDR.
Provide support for
CE marking activities
within SGS, contribute to the
training and qualification of junior staff , and develop comprehensive training materials.
Communicate effectively with team members, clients, and other stakeholders regarding
product assessments , working diligently to minimize regulatory risks associated with
in vitro diagnostic device certification .
Expand and keep up-to-date your knowledge of relevant
technologies, regulations, international standards
and best practice guidance documents.
Qualifications:
At least
4 years of professional experience
within the domain of healthcare products or in related activities.
This may include roles in design and development, manufacturing, auditing, relevant academic research, or work in a clinical setting.
Among these, a minimum of
2 years
should involve direct engagement in the
design, manufacture, testing or utilization of specific in-vitro diagnostic devices and technologies , or relevant scientific research.
Knowledge encompassing a range of
IVR/IVS/IVP/IVD competence codes
for IVDR, as defined in Commission implementing regulation (EU) 2017/2185.
Degree
or equivalent qualification in a relevant technical discipline such as
medicine, engineering, biomedical science, microbiology or biochemistry.
Proficient communication skills
using modern electronic platforms.
Strong
written English skills , as reports will be reviewed and queried in English.
Demonstrated skills in
independent learning.
Desirable Skills:
Direct experience with
medical device development life cycle processes , regulatory submissions and relevant standards such as
ISO 13485 and ISO 14971.
Experience with
clinical studies and clinical performance evaluation
of in-vitro diagnostic devices.
A broad base of experience covering a variety of different
diagnostic assay types and technologies.
Prior experience in conducting
product technical documentation assessments
for another
Conformity Assessment Body / Notified Body
(technical file reviewer or equivalent role) would be considered advantageous.
An in-depth knowledge of the
European regulatory framework on medical devices
is highly advantageous, but is not required to apply for this role as on-the-job training will be provided.
Additional Information:
Why SGS?
Join a globally
recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.
Enjoy a
flexible schedule and a fully remote work model.
Access SGS University and Campus for continuous learning options.
Thrive in a
multinational environment , collaborating with colleagues from multiple continents.
Benefit from our
comprehensive benefits platform.
Join Us:
At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork.
We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential.
Apply now
to be part of our motivated and dynamic team!
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