Glidewell Dental · 3 months ago
Regulatory Affairs Specialist, Sr.
Irvine, California
Full-time
Onsite
Senior Level
$84K/yr - $120K/yr
5+ years expGlidewell Dental is an industry leader in dental technology, known for its agility and cutting-edge innovations. The Senior Regulatory Affairs Specialist will be responsible for preparing and submitting product registrations to regulatory bodies, maintaining company registrations, and supporting compliance with applicable regulations and guidelines.
BiotechnologyDentalManufacturingMedical
Responsibilities
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
Qualification
Required
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
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
Bachelor's degree in related field preferred
Minimum five (5) years of experience in Regulatory Affairs
Benefits
Medical
Dental
Vision
401K with company match
Company-paid life insurance
Additional onsite dental services
Vacation
Holiday
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!
Company
Glidewell Dental
Glidewell is America’s largest digital dental lab, pioneering industry-first innovations that expand what’s possible in restorative dentistry.
1001-5000 employees
H1B Sponsorship
Glidewell Dental has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (28)
2023 (18)
2022 (23)
2021 (30)
2020 (38)
Funding
Current Stage
Late StageLeadership Team
Sergei Azernikov
VP of CAD/CAM Software Development
Recent News
EIN Presswire
2025-09-12
2025-05-17
Company data provided by crunchbase