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Medical Documentation Specialist
2 months ago
Job Overview
SHL Medical is seeking a skilled Medical Documentation Specialist to create high-quality documentation for internal processes and procedures. As a key member of our team, you will collaborate with subject matter experts to develop comprehensive documentation that meets company and regulatory standards.
Responsibilities
- Develop, revise, and standardize SOPs, Work Instructions, and other technical documentation.
- Collaborate with various departments to gather information and ensure the accuracy of technical documents.
- Translate complex technical concepts into easily understandable content for diverse audiences.
- Ensure all documentation complies with company policies, industry standards, and regulatory requirements.
- Review and edit existing documents to ensure they are current and reflect operational changes.
- Maintain a centralized repository of all technical documents and ensure easy accessibility.
- Assist in training and onboarding by providing clear and comprehensive documentation for procedures.
Required Qualifications
- Bachelor's degree in Technical Writing, English, Engineering, or related field.
- 2-5 years proven experience as a Technical Writer or related experience, preferably in a manufacturing, engineering or regulated environment.
- Excellent written and verbal communication skills with attention to detail.
- Strong organizational skills with the ability to manage multiple projects simultaneously.
Preferred Qualifications
- Experience in the medical device industry.
- Knowledge of ISO 13485, FDA 21 CFR Part 820, and GMP Standards.
- Familiarity with ISO 14971 for risk management in medical device production.
