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.
Job Description
Are you ready to
take your career to the next level
?
If you have a strong background as a
Product Assessor
within an EU
notified body
conducting MDD/MDR technical documentation review, then we have an
exhilarating opportunity
for you!
Join our
dynamic team at SGS
and become a
Senior Product Assessor - Active Devices
.
This role will allow you to make a
significant impact
in the field of
certification
.
Your responsibilities will include:
Supporting and guiding your team of talented
Product Assessors
Conducting thorough technical documentation reviews and ensuring
compliance with EU regulations and standards.
Collaborating with
cross-functional teams
to increase
efficiency and quality
Monitoring the team's
technical competence, KPIs, and wellbeing
and providing feedback and support when there are concerns.
Conduct
recruitment
, including reviewing CVs and undertaking interviews and supporting with
onboarding of new starters
Develop
training
and present the training to others in SGS or externally as deemed necessary.
Assist with
technical queries
and those related to
sales within the Active Medical Devices field
.
Ensure that the
highest level of service is provided
throughout the SGS network offering medical devices
certification
and stakeholders through
efficient service delivery
.
Qualifications
To be eligible for this role, you should have prior experience as a
Product Assessor/Specialist/Technical File Reviewer
within another
Notified Body
for active devices, conducting reviews
against MDD and/or MDR
.
Additionally, you must possess:
Four years of
professional experience
in the field of
healthcare products
or related activities, such as design, manufacturing, auditing, or research, of which two years shall be in the design, manufacture, testing, or use of the device or technology to be assessed or related to the scientific aspects to be assessed;
Active Medical Devices knowledge
(monitoring equipment, therapeutic devices, devices utilizing radiation, stand-alone software devices, etc.)
through designing, manufacturing, or testing of such devices;
Thorough knowledge and understanding of related
standards: EN 60601, EN 62304, EN 62366, etc.
;
Good written
English skills
(as reports will be reviewed/queried in English); Knowledge of the following
Technical File codes desirable
(as per COMMISSION IMPLEMENTING REGULATION (EU) 2017/2185 of 23 November 2017):
MDA0201, MDA0202, MDA0203, MDA0204, MDA0301, MDA0302, MDA0303, MDA0304, MDA0305, MDA0306, MDA0307, MDA0308, MDA0309, MDA0310, MDA0311, MDA0312, MDA0313, MDA0314, MDA0315, MDA0316, MDA0317, and MDA0318.
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
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!