Jr. Regulatory Affairs Specialist

Jr. Regulatory Affairs Specialist
Irvine, CA- (100% onsite)
Contract to hire
$30- $31.25 an hour

Immediate hire for a Jr. Regulatory Affairs Specialist that will support product development teams to deliver regulatory inputs, strategies, reports and other design control deliverables. Prepare Quality Assurance/Regulatory reports and present status in review meetings. Prepare reports and documents necessary for Regulatory Agency submissions or in support of customer QARA needs. Perform research to determine Regulatory requirements of product markets & product requirements. Support internal, agency and customer audits and any resulting nonconformity / improvement actions. Support safety inspection findings. Support recurring and new product and facility licenses, listings, technical files, submissions. Maintain and support material controls and deliverables to meet requirements of RoHS, REACH, Conflict Minerals, Prop 65, and other applicable material controls. Support/fulfill requirements related to CAFDB, USFDA, EU MDR, UK MDR, Health Canada, OSHA, DTSC, OC Health, and other regulating agencies. Maintain current procedures. Prepare and support deliverables for 510K and CE Marking submission documents and maintain records.

Requirements:

• Must have a Science degree
• One or more years of experience in Quality with medical device manufacturing background.
• Must be competent with requirements of 21 CFR Quality System Regulations/cGMPs and ISO 13485 Quality System Standard.
• Ability to research, write and support regulatory strategies and supporting documentation/reports.
• Must be proficient in scientific technical writing.
• Must have experience working with ISO Quality System Standard and Quality System Regulations.

• Knowledge and experience with Medical Device Single Audit Program (MDSAP) and EU/UK medical device regulations a plus.
• Proficiency in Access and ERP systems a plus.

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