Sr. Regulatory Affairs Specialist

PRISMATIK DENTALCRAFT, INC.; Irvine (CA); On-site; USD 83,000 - 120,000; Full time

Job summary

A leading company in medical equipment manufacturing is seeking a Senior Regulatory Affairs Specialist in Irvine, CA. The role involves regulatory submissions, compliance audits, and maintaining registrations across multiple regions. Candidates should have a relevant bachelor's degree and a minimum of five years' experience in the field.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• Minimum five (5) years of experience in Regulatory Affairs.
• Experience in preparing domestic and international product submissions required.

Responsibilities

• Prepare and submit product registrations and submissions to FDA and other regulatory bodies.
• Maintain company registrations and device listings in the US, Canada, and the EU.
• Conduct audits and inspections of GMP documentation.

Skills

Regulatory Affairs

Analytical Skills

Education

Bachelor’s degree in related field

Job description

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PRISMATIK DENTALCRAFT, INC. provided 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

$83,898.06/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.
• 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.

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.

Pay Range: $83,898.06 - 120,000.00/yr

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Medical Equipment Manufacturing

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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