Regulatory Affairs Specialist

Regulatory Affairs (RA) Specialist
We currently seek a high caliber Regulatory Affairs Specialist for a long-term basis within our client’s team of experienced professionals. Based in Los Angeles County, CA

Summary of position:

The RA Specialist will provide administrative and technical support to ensure compliance with all FDA and other U.S. and international regulatory requirements.

Requirements / Must haves:
• 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 audits
• Has a desire to function as a team member by listening, asking questions, collaborating, and contributing on daily basis
• Organized and able to perform in a time-sensitive environment
• Comfortable with prioritizing and managing multiple assignments
• Demonstrates a flexible and collaborative approach with various cross-functional teams
• Able to draw on diplomatic communication skills

Job Duties:
• 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
• Process document legalization, authentication and apostille 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

Employment Type: Direct hire
Location of Position: Los Angeles County, CA
Location Type: Office/Facility

To apply for this opportunity, please contact Ora Chak; email: Ora.Chak@trsstaffing.com

TRS 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.