PRISMATIK DENTALCRAFT, INC. ยท 2 weeks ago
Sr. Regulatory Affairs Specialist
Irvine, CA
Full-time
Onsite
Mid, Senior Level
$83K/yr - $120K/yr
5+ years expPrismatik Dentalcraft is a division of Glidewell Dental. They are seeking a Senior Regulatory Affairs Specialist to prepare and submit product registrations to FDA and other regulatory bodies, maintain company registrations, and ensure compliance with applicable regulations.
Medical Device
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
Minimum five (5) years of experience in Regulatory Affairs
Experience in preparing (writing) domestic and international product submissions, required
Preferred
Bachelor's degree in related field preferred
Company
PRISMATIK DENTALCRAFT, INC.
PRISMATIK DENTALCRAFT, INC. is a Glidewell Dental company.
Founded in 2005Newport Beach, California, US
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase