Medical Technical Writer, Frisco, TX

We are hiring for a Medical Technical Writer to join the RAQA team at our Frisco, TX facility.

Job Description: The MedicalTechnical Writer is responsible for assisting in the drafting and assembly of Regulatory Support documents such as Clinical Evaluation Reports, Clinical Evaluation Plans, Post-Market Clinical Follow-up (PMCF) Plans, and PMCF Reports.  Where needed, this position will do the research necessary to gather the required information, including searches of clinical literature databases and reviews of the articles found, and work with technical teams (RA/QA/R&D) as needed to gather the required information to support the creation of crucial documentation.  This individual will review the clinical literature for applicability, analyze the data from the literature as well as clinical investigation results, customer surveys, and other field performance data to present an accurate portrayal of the clinical outcomes of procedures involving Argon products and similar devices.

The Medical Technical Writer gather and review technical documentation summaries, Risk Management Files, Pre-Clinical Test Reports, Instructions for Use, and PMS reports, and further analyze and synthesize these data and reports as needed to prepare and finalize clinical documents. This individual will regularly interface with stakeholders from key functional areas to obtain the necessary information and materials (e.g., technical files, risk reports, IFU, etc.) required for CER content to generate technical documents based on corporate guidelines and priorities. 

This individual will contact outside consultants and other project team members for technical data to support technical writing as needed and will work with the RAQA team to complete assigned tasks within the deadlines. 

Medical Technical Writer Education and Experience Requirements: 

• BS degree required, Master's or Ph.D. preferred with a focus in biomedical engineering or medical fields such as MS, DDS, MPharm or MBBS
• 2+ years of experience in a regulated healthcare environment (ISO 13485:2016/ and 21CFR 820), the medical device industry is preferred
• Previous experience in CER writing according to MEDDEV 2.7/1 Rev. 4 is preferred
• Understanding of regulations and standards and guidelines related to medical devices, clinical studies, and quality systems
• Advanced experience with MS Office suite and Adobe products; able to efficiently create and tabulate technical documentation of a quality suitable for publication
• Excellent written, verbal, and presentation skills in English with the ability to write in an explanatory and procedural style for multiple audiences. 

The Regulatory Technical Writer will be responsible for all document editing and quality control, including quality review of accurate data presentation and bibliography, ensuring correctness of document content, preparing finalized documents for submission to regulatory authorities and notified bodies. This individual will work to assist in the development of therapeutic and Argon device operation knowledge and apply this knowledge to generating technical documents based on corporate guidelines and priorities. This role will work cooperatively with others to produce innovative solutions. 

Argon Medical is a global manufacturer of specialty medical products, including a broad line of medical devices for Interventional Radiology, Vascular Surgery, Interventional Cardiology, and Oncology. With over 800 employees worldwide. Argon has manufacturing facilities located in Athens, TX, Wheeling, IL and Rochester, NY. Argon's brand is recognized for best-in-class products that improve patient outcomes via percutaneous, image-guided procedures. https://www.argonmedical.com/about/our-company.

If you are interested in hearing more about this Distribution Supervisor, contact a recruiter today at Andrew.Foran@argonmedical.com or apply online www.argonmedicaljobs.com