PM Group is a world class engineering, architecture and project management company.  Headquartered in Ireland, we also operate in the UK, Europe, Asia, USA and the Middle East. 

Job Title Senior Technical Writer

Our client requires a Senior Technical Writer for a role based in Limerick

Job Role and Responsibilities:

• To provide support for the technical/validation documentation activities
• Ensuring that all compliance issues and requirements of Company Validation/Quality Policies and Procedures are addressed
• Perform technical writing, research, and related editing functions to prepare documents, test plans, user cases, project manuals, business proposals, reports, briefings, presentations, guidelines, and other written materials
• Establishes and manages engagement objectives, expectations, and quality plan
• Suggest and may implement innovation and continuous improvement within the technical/validation writing process
• Builds cross functional and cross-departmental support, fostering overall effectiveness
• Ensure accuracy and consistency of the technical/validation documentation
• Ensure all quality/validation documents are authorized and appropriate compliance approval is gained

Qualifications:

• Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Science with additional IT qualification) with a broad technical/educational skills base
• Knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with the medical device industry
• Understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations
• Experience working in a regulated environment would be an advantage

All CV’s are treated in the strictest confidence

RECRUITMENT AGENCIES NEED NOT APPLY