Job description

Job Summary

Stark Pharma Solutions Inc is searching for a skilled Technical Writer to join a medical device company under a contract basis of 6 months or longer. The position is fully remote and involves crafting and managing technical documentation that complies with strict regulatory standards such as FDA 21 CFR Part 820 and ISO 13485.

Responsibilities

Create, update, and sustain comprehensive technical documents including SOPs, work instructions, system documentation, and various technical reports.
Convert advanced engineering and scientific concepts into clear and accessible manuals and documentation.
Develop and implement documentation templates, style guides, and ensure proper version control procedures.
Produce and maintain technical diagrams, process maps, and supplementary visual aids.
Ensure documentation accuracy, consistency, and adherence to quality and regulatory standards through rigorous review.
Collaborate closely with Engineering, Research & Development, Quality Assurance, and Regulatory Affairs teams to reflect current processes in all documents.
Assist in audits by preparing and keeping audit-ready documentation in line with regulatory requirements.
Manage several documentation projects simultaneously in a fast-moving, regulated environment.

Qualifications and Skills

Bachelor’s degree in fields such as Technical Communication, Engineering, Biomedical Science, English, or related disciplines.
Minimum of 3 years of technical writing experience within the medical device, pharmaceutical, or life sciences sectors.
Comprehensive knowledge of FDA 21 CFR Part 820 and ISO 13485 documentation standards.
Proven expertise in drafting SOPs, work instructions, technical manuals, and related documentation.
Strong writing, editing, organizational and communication skills, with meticulous attention to detail.
Ability to efficiently handle multiple projects and deadlines.

Additional Information

This opportunity is for a remote contract role requiring at least six months commitment. Interested professionals with relevant experience in regulated environments are encouraged to apply. Contact information and company details are provided for further communication.