PR/086904 | Regulatory Affairs and QA Supervisor (Onsite in San Diego, CA)

RESPONSIBILITIES

• Facilitates audits by interacting with FDA, ISO, and international regulatory bodies.

• Manages the 510k regulatory submission process by compiling and submitting the necessary reports and documentation to internal and external submission partners.

• Works closely with Quality and the Risk Management team to identify and mitigate risk/issues.

• Files Vigilance Reports or MDR (Medical Device Report) to Competent Authority or FDA.

• Interacts between departments to coordinate and facilitate submissions.

• Maintains full awareness of all regulatory activities on assigned projects and ensures that project deadlines and performance standards for these projects are established and met.

• Works to minimize regulatory issues and helps prevent unnecessary regulatory delays.

• Evaluates changes to regulatory documents and formulates a strategy to ensure proper filing categories.

• Plan and implementation and maintenance of the QMS.

• Conduct internal audits to ensure compliance.

• Manage quality control over the entire submission lifecycle, including all component tracking, workflow execution and issue resolution.

• Evaluate changes and signs-off on change control documents, ensuring the correct filing category.

• Represent Quality Assurance on project teams interdepartmentally.

• Performs other duties, as assigned, or as business needs require.

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REQUIREMENTS
 

• Minimum 3 years of QA/RA experience required

• Bachelor's degree from four-year college or university; or 3+ years related experience and/or training

• Japanese language skills (Preferred)
   
• Excellent understanding of Food and Drug Administration (FDA) and international organization for standardization (ISO) regulations

• To perform this job successfully, an individual should have knowledge of: Database Software (EPDM); Spreadsheet Software (Excel); Project Management Software; Word Processing Software (Word); Electronic Mail Software (Outlook); Presentation software (PowerPoint).

• Regulatory Affairs Certification Program (Preferred)

• USD 90,000 - 110,000 DOE

• Comprehensive health benefits, 401k, PTO

   
• Onsite in San Diego, CA
   
• This role is NOT visa sponsored

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