Medical Writer – Regulatory

Glidewell Laboratories is the industry leader in dental technology due to our agility, speed, and cutting edge technology. We work in a fast-paced and highly sought-after employee-friendly work environment. Behind all of this success is an amazing group of people who are passionate about bringing innovation to the marketplace, while providing quality and affordability to better the lives of people all over the world. If you share in our passion for teamwork and a vision for excellence, let's talk about a rewarding career at Glidewell!

• Researches, compiles, and edits subject matter related to dental industry using PubMed, Google Scholar, and Cochrane databases; determines relevant datasets to extract and incorporate into literature.
• Creates Clinical Evaluation Reports (CER) and other technical documents including but not limited to procedure manuals.
• Sets timelines for completion and updates of CERs.
• Develops documentation for instructional, descriptive, reference and/or informational purposes.
• Conducts interviews and reviews internal documents and business analytics to develop reports and documentations.
• Integrates various sources of information into a uniform style and language.
• Interviews subject matter experts (SMEs) to write, rewrite, or clarify research or review articles.
• Collaborates with the Research and Development (R&D) team to ensure standard operating procedures (SOPs) are adhered to; recommends changes to workflow.
• Creates and updates SOPs as needed.
• Leads post-market surveillance activities to gather data on competitors; analyzes and prepares PMS report on data.
• Responds to auditors' questions.
• Collaborates with the Complaints Department as an advisor for the complaints process.
• Perform other related duties and projects as business needs require at direction of management.

• Bachelor’s degree required. Master’s degree, DDS, PharmD, PhD or equivalent level of education.
• Minimum five (5) years of experience within the medical device industry; experience in dental industry preferred.
• Minimum three (3) years of experience in writing Clinical Evaluation Reports and Post Market Surveillance Reports.
• Knowledge of US and international regulatory requirements pertaining to medical devices preferred.
• Experience in complaint handling and adverse event reporting preferred.