Content Writer-medical Device

3 days ago


Bengaluru Karnataka, India NeST Digital Full time

Minimum Required Experience : 5 years

Contract

**Skills**:

- Content Writing
- Iso 13485
- Iec 62304
- Fda Standards

Description

**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



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