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:
- Bachelor’s degree required. Master’s 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