BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Regulatory Affairs Specialist to work for a leading San Diego biotechnology company.
Regulatory Affairs Specialist (contract)
Review and retrieve relevant information from several resources [e.g. risk assessment, hazard analysis documents (FMEA, PFMEA, etc.), design input and verification documents, DHFs, etc.] and transfer the information to several spreadsheets required by the IEC 60601-1. Provide support to the Team and work closely with QA/RA, Engineering and Marketing personnel to effectively gather information in order to complete all product submissions.
4 year degree.
Engineering experience in the medical device field, having worked with verification/validation, hazard analysis and risk analysis protocols, reports, procedures and work directions according to Quality System Regulations and FDA and ISO standards.
Quality Systems: QMS design and implementation (ISO13485), Equipment validation (IQ, OQ and PQ) and Risk management/mitigation (using ISO14971)
Quality Control: IQC, In-process QC and Final release/OQC process design (using AQL), implementation and validation (OQ and PQ),
Some experience working in Manufacturing Engineering in production lines on process improvements and problem solving ideas.
Some exposure to performing failure analysis of field-returned product, investigation of Customer Complaints, and Corrective Action and Preventative Action (CAPA). Change order requests for changes to existing products.
BioPhase Solutions - 13 months ago