PRISMATIK DENTALCRAFT, INC.
Sr. Regulatory Affairs Specialist
PRISMATIK DENTALCRAFT, INC., Irvine, California, United States, 92713
PRISMATIK DENTALCRAFT, INC. Pay Range
This range is provided by PRISMATIK DENTALCRAFT, INC.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base Pay Range
$83,000.00/yr - $120,000.00/yr Prismatik Dentalcraft is a division of Glidewell Dental. 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. 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. Education and Experience
Bachelor’s degree in related field preferred. Minimum five (5) years of experience in Regulatory Affairs. Experience in preparing (writing) domestic and international product submissions, required. Benefits
Medical insurance Vision insurance 401(k) Referrals increase your chances of interviewing at PRISMATIK DENTALCRAFT, INC. by 2x
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This range is provided by PRISMATIK DENTALCRAFT, INC.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base Pay Range
$83,000.00/yr - $120,000.00/yr Prismatik Dentalcraft is a division of Glidewell Dental. 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. 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. Education and Experience
Bachelor’s degree in related field preferred. Minimum five (5) years of experience in Regulatory Affairs. Experience in preparing (writing) domestic and international product submissions, required. Benefits
Medical insurance Vision insurance 401(k) Referrals increase your chances of interviewing at PRISMATIK DENTALCRAFT, INC. by 2x
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