Technical documentation Executive

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