Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Key Responsibilities
Create, revise, and publish high-quality
Instructions for Use (IFU)
in alignment with current procedures, regulatory expectations, and market needs.
Ensure documentation complies with
QSR, ISO
, and other internal quality and regulatory standards.
Coordinate translation activities with external translation agencies and internal stakeholders to ensure linguistic accuracy and timely delivery.
Maintain adherence to company
style guides
, templates, and quality management systems (QMS).
Collaborate cross-functionally with teams such as
Product Development, Regulatory Affairs, Quality Assurance, Marketing, and Global Operations
to gather information and validate technical accuracy.
Drive and manage activities within the assigned area of responsibility.
Contribute to the
continous improvement
of documentation standards, templates, and processes.
Support
Deviation, CAPA, and complaint investigations
by providing documentation expertise and contributing to corrective action processes.
Qualifications & Experience
Bachelor’s or Master’s degree
in Technical Communication, English, Journalism, Life Sciences (e.g., Biology, Biochemistry, Molecular Biology), or a related field; equivalent professional experience will be considered.
2–3 years of technical writing experience
within the life sciences, medical device, or in vitro diagnostics (IVD) industry.
Excellent English,
including speaking, writing, and editing skills.
Strong understanding of
regulated content development
, including usability, risk communication, and labeling requirements.
Hands-on experience with
content management systems (CMS/CCMS)
, ideally in
DITA/XML
structured authoring environments.
Proven ability to manage multiple documentation projects in a
global, fast-paced, and regulated environment
.
Experience working with
translations and simplified English.
Experience with
EU IVDR
documentation requirements.
Preferred Skills
Proven ability to create
clear, compliant, and user-friendly content
for laboratory technicians, clinicians, and regulatory reviewers.
Multilingual skills
(e.g., German, French, Spanish) to support localization and translation processes.
Experience in use of
reusable content strategies
to drive consistency and efficiency.
Strong
cross-cultural communication and collaboration skills
, with flexibility to work in a dynamic, global team setting.
High
attention to detail,
accuracy, and a commitment to continuous improvement.
Demonstrated t
echnical curiosity and interest
in understanding complex products and systems.
Good
collaborator with clear communication skills
.
Ability to work both independently and in collaboration with others, as well as the ability to handle both small and large tasks.
Experience with
EU MDR
is an advantage.
