Job Description

Job Title:

Technical Documentation Executive

Department:

Regulatory Affairs / Compliance

Location:

[Insert Location or mention Remote]

Job Type:

Full-Time

Job Summary:

We are seeking a detail-oriented and technically proficient

Technical Documentation Executive

to support the preparation and maintenance of regulatory documentation, especially for

CE Certification

of technical products. The ideal candidate must have a strong grasp of regulatory requirements, documentation standards, and be

highly skilled in Microsoft Excel

for data analysis, documentation tracking, and report generation.

Key Responsibilities:

Prepare and manage technical documentation

in alignment with

EU Directives

and other relevant

regulatory frameworks

for

CE Marking

.

Compile and format Technical Files (TF)

and

Declarations of Conformity (DoC)

to support

CE Certification

submissions. Collaborate with

cross-functional teams

(R&D, QA, Regulatory Affairs) to collect, verify, and organize

product information

,

test data

, and other supporting documents. Maintain

document version control

and ensure all records are consistently

audit-ready

, current, and aligned with regulatory requirements. Utilize

Microsoft Excel

extensively to manage

data sheets

, generate analytical

reports

, and track

certification timelines

, testing schedules, and compliance status. Assist in preparing responses to

Notified Bodies

and other

regulatory authority

inquiries with clear, accurate, and compliant documentation. Ensure strict adherence to

document retention policies

, approved

templates

, and evolving

regulatory standards

. Contribute to the

continuous improvement

of documentation procedures, templates, and formatting guidelines for enhanced efficiency and clarity.

Required Qualifications & Skills:

M.Tech in Mechanical Engineering

or related technical field;

B.Tech in Mechanical Engineering

also acceptable with relevant experience. Minimum 1-3 years of experience in

technical documentation

, preferably in

Technical

,

engineering

, or

regulatory affairs

domains. Strong understanding of

CE Certification

processes and applicable

EU regulations

Advanced proficiency in

Microsoft Office

, including formulas, pivot tables, data validation, charting, and document automation. Excellent written communication skills with meticulous attention to detail and accuracy. Ability to work independently and manage multiple documentation projects effectively. Familiarity with

ISO standards

,

risk management files

,

usability reports

, and

clinical evaluation documentation

is an advantage.
Job Type: Full-time

Pay: ?22,000.00 per month

Location Type:

In-person
Schedule:

Day shift Morning shift
Work Location: In person