MEDICAL WRITER - REGULATORY

Prismatik Dentalcraft is a division of Glidewell Dental.

Essential Functions :

Research, compile, and edit 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 Regulatory Affairs as an advisor for the complaints process.

Education and Experience :

• Bachelors degree required. Masters degree, DDS, PhD or equivalent level of education.
• Minimum eight (8) years of experience within the medical device industry.
• Knowledge of US and international regulatory requirements pertaining to medical devices preferred.
• Experience in complaint handling and adverse event reporting preferred.
• Experience in dental industry preferred.
• Experience writing Post Market Surveillance and Clinical Evaluation Reports.

Knowledge, Skills, and Abilities :

• General knowledge of office procedures.
• Proficient skills in the MS Office suite (Excel, Word, and Outlook).
• Demonstrated ability to maintain organized reports.
• Ability to read and understand all operating procedures and applicable technical information.
• Ability to work independently and effectively contributing as a team player.
• Must be a self-starter with a strong sense of self-development.
• Must possess a strong work ethic, emphasizing both efficiency and quality of work.
• Demonstrated time management skills.
• Demonstrated attention to detail and accuracy.
• Ability to write scientific literature reviews.
• Demonstrated knowledge of Clinical Evaluation Reports as mandated by FDA, Health Canada, and EU regulations.
• Ability to write new operating procedures based on documentation including process flow maps, requirements descriptions, and existing procedure documents where applicable.
• Demonstrated knowledge of and ability to use PubMed, Google Scholar, and Cochrane databases.

Pay Range : $83,000-$138,000 / YR