Content Writer-Medical device

Job Description

Minimum Required Experience : 5 years Contract Skills Content Writing Iso 13485 Iec 62304 Fda Standards Description Overview: We are seeking a skilled Content Writer to join our medical device development team. The ideal candidate will possess a strong understanding of regulatory standards such as ISO 13485, US FDA regulations, IEC 62304, and cdsco, and will be responsible for creating clear, accurate, and compliant documentation, manuals, and technical content related to our medical devices. Key Responsibilities: Develop and maintain technical documentation, user manuals, and standard operating procedures (SOPs) for medical devices. Ensure all content complies with regulatory standards including ISO 13485, FDA guidelines, IEC 62304, and cdsco. Collaborate with engineers, quality assurance, and regulatory teams to gather technical information. Write, review, and edit content to ensure clarity, accuracy, and regulatory compliance. Support the creation of training materials and internal documentation through out the medical device development life cycle. Stay updated with changes in medical device regulations and standards, integrating them into documentation. Qualifications & Skills: Proven experience in technical writing within the medical device or healthcare industry. Strong knowledge of ISO 13485, US FDA regulations, IEC 62304, and cdsco standards. Excellent written and verbal communication skills. Ability to translate complex technical information into clear, user-friendly content. Familiarity with medical device development lifecycle and regulatory pathways. Bachelor’s degree in Life Sciences, Biomedical Engineering, Technical Writing, or a related field. Preferred: Experience working in regulated environments. Prior experience with documentation for software as a medical device (SaMD). Knowledge of medical device risk management and quality management systems