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Technical Writer

Company: gpac
Location: Longmont
Posted on: January 11, 2022

Job Description:

You will be part of the team that is spearheading the development of end-to-end solutions for remote respiratory monitoring, and clinical laboratory solutions and services for detection and monitoring of pulmonary health. The developed solutions will help patients and doctors to better manage patients' respiratory health and improve clinical treatment outcomes. If you want to work on purpose driven technologies to improve people's lives, then join our team!

Overall Job Summary
Near term activities to be compliant with MDR requirements:

Lead the technical writing for conversion of existing Tech Files to an MDR compliant format
and providing consultation on gaps and closure. Develop best practice and efficient approaches
and methodologies to address established, changed and new legislation, regulation and guidance
on technical documentation with initial focus on the new EU MDR requirements.

Ongoing Activities to be compliant with regulatory requirements on a global scale:

Interpret & assess domestic and global regulatory requirements and make recommendations based on the specific region to ensure new products, new features and capabilities are effective and technical documentation is compliant to introduce to global markets
Stay abreast of all pertinent regulatory affairs issues. Interprets and applies FDA regulations to advise and guide the engineering team to ensure proper design compliance and documentation appropriateness
Works out Regulatory scenarios with company Quality and Compliance team to support decision making in line with technical documentation strategy.
Other responsibilities include providing regulatory support for currently marketed products, including the review of engineering drawings, labeling, technical files, design history files, and engineering change orders.
Active follow-up on the progression of technical documentation activities required to successfully and timely complete the deliverables

We Are Looking for The Following Skillset/Experience

Medical Device Regulatory Affairs (5+ years)
Direct experience in creating Design Dossiers or Technical files for CE submission
Working knowledge of the EU Medical Device Regulation
Cross functional understanding of Design Control and Clinical Affairs as required to support RA submissions
Working knowledge of FDA Medical Device Regulation including software as medical device

Keywords: gpac, Longmont , Technical Writer, Engineering , Longmont, Colorado

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