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Regulatory Affairs/Quality Assurance Specialist

California, Glendora
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Our client is seeking a Regulatory Affairs /Quality Assurance Specialist to join their team of professionals. This position is based in Glendora, CA.Primary Function:Provide administrative and technical support to ensure compliance with all FDA and other U.S. and international regulatory requirements.Requirements:• B.S. in Business or a related technical field preferred• Minimum 5 years knowledge and experience in Regulatory Affairs and Quality Assurance in the manufacture of sterile, disposable medical devices• Strong understanding of FDA Quality System Regulations, Medical Device Directive and ISO 13485 regulations• Proven ability to maintain ongoing compliance in a regulated environment• Able to organize and maintain detailed regulatory and quality records/documentation• Excellent written and verbal communication skills• Works well independently and as a team member• Knowledge and/or experience in internal and external quality auditsResponsibilities:• Maintenance of domestic and foreign regulations and quality standards• Works with and responds to inquiries from regulatory agencies• Respond to product questionnaires from customers• Maintains Technical Files in compliance with the European Medical Device Directive• Prepare and provide regulatory information and documents needed for product import or export• Collaborate with Sales and Marketing personnel to identify global regulatory requirements for international product registrations• Issuance of certificates of origin and/or conformity as requested• Request FDA Certificate to Foreign Government, Certificate of Exportability as needed• Support the preparation and submission of product applications and license amendments to Health Canada• Provide support, create and maintain documents, correspondence, memorandums, etc. pertinent to Quality Assurance and Regulatory Affairs activities• Maintain Establishment Registrations, Device Listings and State Licenses• Other responsibilities as assignedTo apply for this opportunity, please contact Ann Pringle at 949-349-4922 or ann.pringle@trsstaffing.comTRS Staffing Solutions is an Equal Opportunity Employer that recognizes the value of a diverse workforce. Employment decisions are based on job related criteria and not on the basis of any unlawful criteria. We ensure equal access to employment opportunities, services, and programs. Must have legal right to work in the United States. We thank all applicants for their interest; however, only those selected for interviews will be contacted

Aliso Viejo
Ann Pringle
Job reference ID:
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TRS Staffing Solutions is an equal opportunity employer that recognizes the value of a diverse workforce.  All qualified individuals will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, genetic information, or any other criteria protected by federal, state or local law.

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