Documentation Development:
- Collaborating with subject matter experts to write product documentation, including user manuals, system guides, repair manuals, field service manuals, etc.
- Disseminate technical information in easy-to-understand language for non-technical audiences.
- Create software documentation after a thorough collaboration with subject matter experts.
- Determine the needs of end users for better technical documentation.
Content Review and Quality Assurance:
- Continuously improve and update existing technical content, marketing materials, and website to ensure accuracy and completeness of the information.
- Support in reviewing the technical documentation for regulatory submissions, design documentations, and clinical documents.
- Conduct proofreading, editing, document formatting, review comment incorporation and document completion / approval activities.
Regulatory and Compliance Support:
- Participate in the development and review of documentation, for global regulatory submissions, adapting content to meet specific regional requirements.
- Support technical/clinical/regulatory writing for global regulatory submissions in electronic format, when needed.
- Ensure all documentation is aligned with regulatory standards, formatted for compliance, and approved by relevant stakeholders.
- Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D, Clinical, Sales and Marketing, Quality Assurance, as well as external vendors such as CROs, if applicable).
Clinical Evaluation Support:
- Perform literature searches on various databases.
- Write and edit, as needed, Clinical Evaluation Plans and Clinical Evaluation Reports, and other clinical CER deliverables.
Minimum requirements:
- Experience: Minimum of 4 years of experience in technical writing. Medical device industry experience will be preferred.
- Soft skills: Strong communication skills, effective in a complex, global organization. Ability to work as Individual Contributor and take ownership.
- Effective interpersonal skills: Ability to work collaboratively with cross-functional teams. Should be able to multi-task, managing multiple project activities and organizational responsibilities effectively. Agile thinker and learner, adaptable to dynamic environments.
- Technical skills: Excellent technical/scientific writing skills. Good understanding of medical device product development would be an added advantage.
- Education: Bachelor's degree in engineering or related field. Advanced degree in engineering or scientific discipline preferred.
- Languages: Verbal and written fluency in English.
