Regulatory Affairs Specialist

Prismatik Dentalcraft is a division of Glidewell Dental.Essential Functions:Serves as Regulatory Affairs subject matter expert (SME) on designated projects and product development to ensure compliance through all phases of development. Provides project and product guidance, feedback, and recommendations as necessary to support compliance.Participates in development meetings and collaborates with appropriate project teams on any issues of non-compliance.Determines requirement and prepares and submits company registrations for State LicensingPermits accordingly.Prepares, submits, and oversees designated product registrations and (510(k)) submissions to FDA and other regulatory bodies.Prepares, submits, and oversees designated domestic and international submissions. Serves as point contact for FDA, regulatory bodies, and various agencies during submission processing and review to resolve inquiries and increase approval effort.Serves as co-author for 510(k) submissions, partnering with appropriate team members on complex submission and providing insight as necessary to support clearance. Monitors compliance with existing regulationsstandardsguidance and upcoming or changing regulationsstandardsguidance.Reviews and approves design control documents. Evaluates compliance with applicable regulations, project policies, and procedures. Reviews and writes standard operating procedures (SOPs) and other RA policies as necessary.Collaborates with technical staff to foster understanding of SOPs and guidance documentation.Coordinates with international regulatory team members regarding product changes and regulatory notification andor approval requirements.Provides management with ideas for developing and implementing strategies and processes.Reviews and approves advertisements, labels, and public communication documents for regulatory compliance.Reports significant regulatory issues related to a product's release to appropriate parties.Evaluates product compliance to applicable regulations and project requirements.Participates in FDA facility inspection, Notified Body audits, and other government inspections as needed.Maintains RA related files.Maintains company registrations and device listings in the US, Canada, and other countries.Performs other related duties and projects as business needs require at direction of management. Knowledge and Abilities:Proficient knowledge of general office procedures.Proficient skills in the MS Office Suite (Excel, Word, PowerPoint, and Outlook).Proficient quantitative and analytical skills.Demonstrated prioritization and time management skills.Demonstrated knowledge and understanding of related State and Federal regulations and procedures.Demonstrated high standard of quality of work. Demonstrated knowledge of FDA 510(k) and ISO 13485 Standards. Demonstrated knowledge of Regulatory Affairs regulations, guidance, and procedures (Good Mfg. Practice, Good Practices training programs, SOP development, and GMP audits and inspections).Demonstrated reliability, dependability, and flexibility in work habits.Demonstrated attention to detail and accuracy.Ability to prioritize and organize project tasks and goals effectively.Ability to maintain confidentiality, exhibiting high level of integrity, Education and Experience:Bachelor's degree in related field preferred, but not required.Minimum two (2) years of experience in Regulatory Affairs.Experience preparing (writing) domestic and international product submissions, required. Pay Range: $68,000 - $90,000YRGlidewell 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 medicalwellness 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 . Please indicate the specifics of the assistance needed.

Created: 2025-02-24