Description

Position at Prismatik

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

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!

In addition are the following generous employee benefits: Medical, Dental, Vision, 401K with company match, company-paid life insurance, additional onsite dental services, vacation, holiday, and sick time, employee gym (with fitness classes and meditation room), employee medical/wellness center (with massage therapy and acupuncture), two company subsidized cafes, Internet cafes, employee lounges with big screen TVs, game tables, fun company sponsored events, a diverse work environment with over forty nationalities represented, and much more!

Glidewell Laboratories is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. We are committed to the principle of equal employment opportunity for all employees and to provide employees with a work environment free of discrimination and harassment on the basis of race, color, religion, national origin, sex, age, physical or mental disability, veteran status, sexual orientation, gender identity, genetic information, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at [email protected]. Please indicate the specifics of the assistance needed.

Note to Current employees: Please apply through Employee Transfer Application to complete the transfer request form.

Glidewell Dental

New Jobs

Medical Writer - Regulatory