Job Summary

Quality Specialist / Regulatory Affairs

  • Location:
    Irvine, California
  • Job reference:
    US_EN_6_23945_60395466
  • Category:
    Quality Assurance
  • Contract Type:
    Contract/Temp to Hire

ESSENTIAL FUNCTIONS:
1. CE-marking activities and compilation/maintenance of product Technical Files, including formatting to current standards and guidances and preparing new product Technical Files (and/or design dossiers) as required.
2. Maintain and update the listing of applicable domestic and international standards, along with FDA and other governmental authority documents as necessary.
3. Periodic reporting (CDRH reports, device listing, etc.).
4. Assist in ensuring that the Quality System is maintained and up to date (including changes to WIs, QSPs, QM, etc.)
5. Assist in review and approval of labeling, promotional items and change management materials as required.
6. Assist in compilation and submission of domestic and international regulatory submissions (including rationales, etc.).
7. Support international distributors through provision of requested regulatory documentation.
8. Assist in formulating, implementing, and reporting on quality objectives complementary to corporate policies and goals.
9. Interprets quality policy to personnel in organization.
10. Assist in planning and providing support to QC Inspectors on the analysis, inspection, design, test, and/or integration to assure the quality of products or components.
11. Performs reviews and signoff of device history records for release of product to finished goods.
12. Assists in the compilation and review of data obtained during all quality control and quality assurance activities to ensure consistency with company policies and procedures.
13. Provide input on whether to accept a product or recommends whether to continue business with a vendor based on a review by the quality engineer.
14. Analyzes and summarizes data for management review of quality functions.
15. Keeps management team abreast of significant issues or developments identified during quality activities and actions being taken to improve the situation.
16. Maintains approved supplier listing, including initiating supplier evaluations and performing supplier audits.
 
OTHER RESPONSIBILITIES:
1. Interface with other Company departments as required.
2. Support Management Representative in ensuring company-wide regulatory compliance to applicable standards and regulations.
3. Assist during regulatory corrective actions such as recalls.
4. Develops new approaches to solve problems identified during quality activities.
5. Prepares and presents technical and program information to the management team.
6. Directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products
7. Plays active role on quality management teams within organization.
8. Assist with design and implementation of quality training programs to key personnel in conjunction with managers.
9. Use the Internet to research and print various regulatory documents.
10. Assist in third party inspections and audits, internal audits, and vendor audits.
11. Maintain professional and technical knowledge by continuing education.
12. Perform other responsibilities as assigned.
 
EDUCATION, EXPERIENCE AND SKILLS REQUIREMENTS:
1. Possesses willingness to learn complex subjects with a minimum of instruction and/or supervision.
2. Possesses working knowledge of computers (word processing, spreadsheets, databases, etc.).
3. Minimum of high school diploma, with a bachelor’s degree preferred, and three to five years’ experience, preferably in the medical device industry in regulatory and/or quality functions, required.
4. Must be a self-starter and hands-on, with excellent organizational, oral, and written communication skills.
 


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All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Equal employment opportunity information:
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