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Quality Assurance & Regulatory Affairs

San Diego, CA

Order: 66966

We are currently looking for a Quality Assurance and Regulatory Affairs individual to work for a Medical Device company in the San Diego area. In this role you will be responsible for quality and regulatory standards for both product and company operations. If you have previous experience, then we are looking for you!

 

Job Duties

 

Quality Assurance 70% of the role

  • Prepare technical documentation necessary for regulatory submissions

  • Analyze large data sets and assess for compliance with applicable requirements

  • Write and/or edit complex and lengthy technical documents for clarity, grammar, spelling, punctuation and consistency

  • Develop and maintain other technical documentation required for compliance such as policies, SOPs, regulatory content for design history files

  • Document Control under Quality supervision (issue production batch records, provide line clearance, update log sheets for CAPA, Deviations, Product Complaints, SOPs, Forms, etc.)

  • Advise the manager of factors that may affect quality of the product, initiate problem reports for deviations and non-conforming materials, and provide guidance/options and ideas for corrective actions and preventive actions (CAPA).

 

Regulatory Affairs 30% of the role

  • Participate in product development activities, including evaluating and advising personnel on regulatory impact throughout product lifecycle stages, ensuring that regulatory standards are understood, that a design control system is in place, that design validation activities are conducted, and that a Design History File (DHF) is maintained to support regulatory submissions.

  • Support the preparation of regulatory submissions and amendments, including 510ks, and corresponding international submissions, including Technical Files.

  • Review engineering protocols and reports and recommend modifications to enhance the quality or presentation to support regulatory submissions.

  • Assemble reports, amendments, supplements, letters to file, etc. to support Regulatory Submissions.

  • File, update and maintain Regulatory submissions in accordance with current US and foreign regulations for Facility registrations, certifications and licenses.

  • Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.

  • Other duties as assigned

 

Qualifications

  • Bachelor’s degree preferred; equivalent work experience in lieu of degree acceptable.

  • Spanish Bi-Lingual skills required.

  • 3+ years of QA and Regulatory experience is preferred.

  • Ability to read, analyze, and interpret scientific and technical journals.

  • Excellent working knowledge of Microsoft Word, Excel, and PowerPoint.

  • Must be able to freely travel from US to Mexico.