Prismatik Dentalcraft is a division of Glidewell Dental.
We are seeking an experienced Sr. Regulatory Affairs Specialist to support global regulatory compliance and drive high‑impact submissions. In this role, you’ll lead FDA 510(k)/PMA filings, maintain international registrations, support audits, develop SOPs, and partner closely with technical teams to ensure products meet regulatory and quality standards. If you excel at interpreting regulations, managing complex documentation, and guiding teams through compliance requirements, this is an opportunity to make a meaningful impact in a fast‑moving, innovative environment.
Essential Functions:
- Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies.
- Maintains company registrations and device listings in the US, Canada, and the EU.
- Analyzes and reports department metrics.
- Supports and maintains technical files, MDD certifications, and declarations of conformity in support of EU product registrations/CE mark.
- Informs coordinator of product recalls.
- Performs and supports internal, external, and third-party audits.
- Maintains knowledge on current regulations and guidelines.
- Evaluates compliance with applicable regulations, project policies, and procedures
- Reviews and writes standard operating procedures (SOPs) and other RA/QA policies as necessary.
- Collaborates with technical staff to foster understanding of SOPs and guidance documentation.
- Composes audit plans and reports.
- Conducts audits and inspections of GMP and non-regulated documentation.
- Tracks internal and external corrective and preventive actions.
- 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 negotiation abilities.
- Demonstrated knowledge and understanding of related State and Federal regulations and procedures.
- Demonstrated high standard of quality of work.
- Demonstrated knowledge of FDA 510K 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 analyze and collate data for presentations and reports.
- Ability to prioritize and organize project tasks and goals effectively.
- Ability to maintain confidentiality, exhibiting high level of integrity, and trustworthiness.
- Ability to interpret and collate data to present an accurate picture of market potential.
- Ability to research new and emerging technologies and practices.
- Ability to read technical diagrams, graphs, and instructions.
Education and Experience:
- Bachelor’s degree in related field preferred
- Minimum five (5) years of experience in Regulatory Affairs.
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.
Job Type: Full-time
Pay: $86,000.00 - $120,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- On-site gym
- Paid time off
- Vision insurance
Application Question(s):
- Will you now, or in the future, require sponsorship for employment visa status (e.g. H-1B visa status)?
Experience:
- Medical device: 7 years (Required)
- 510k drafting: 4 years (Required)
- Regulatory Affairs: 7 years (Required)
Ability to Relocate:
- Irvine, CA 92612: Relocate before starting work (Required)
Work Location: In person
