Regulatory Affairs Associate
2 weeks ago
Client: IRIDEX
Position: Regulatory Affairs Associate
Location: Mountain View, CA
Contract Length: 5 months
Pay Range: $35 - $45/hr
IRIDEX Corporation is a medical device manufacturer and operates in a global regulated environment (e.g. FDA). Regulations include (but are not limited to) FDA 21 CFR 820, EN ISO 13485, Health Canada SOR/ 98-282, and the European Medical Device Regulation (MDR). Based on the position, experience in a regulated environment and the extent of working knowledge of appropriate regulations may vary.
PURPOSE OF JOB:
The (Temp) Regulatory Affairs Associate – EU MDR Technical Documentation is responsible for preparing Technical Documentation in satisfaction of European MDR 2017/745 requirements, including implementing regulatory practices and procedures for preparing and maintaining Technical Documentation, and coordinating cross functional inputs into Technical Documentation.
The (Temp) Regulatory Affairs Associate – EU MDR Technical Documentation reports to the Regulatory Affairs Director and will work with the Iridex Team (including both Regulatory and Cross-functional colleagues) and consultants to obtain, prepare, and provide information in support of EU MDR submission. This position will involve formally updating Regulatory Documentation within the document control system.
MAJOR DUTIES AND RESPONSIBILITIES:
• Prepare Technical Documentation in satisfaction of EU MDR 2017/745 requirements.
o Prepare and update Technical Documentation files, including: create and maintain Technical Documentation files within the company PLM System (RitePro).
o Coordinate and obtain cross-functional inputs into Technical Documentation.
• Administer regulatory documentation.
o Work with Supervisor to maintain/update EUDAMED and other databases.
o Maintain regulatory files/database and chronologies.
o Implement/oversee change control of updated documents.
• Communicate International requirements to Iridex team.
o Interact with Engineering, Customer Service, Purchasing, Document Control, and Quality Control to obtain documents and test data necessary to support regional registration requirements.
QUALIFICATIONS:
• Education: Bachelor’s degree required, higher education a plus.
• Experience: Strongly preferred 4 years of RA or QA in Medical Device with at least 2 years of familiarity with EU MDR.
• Computer literacy and proficiency in Microsoft Office Suite and Adobe Acrobat.
• Excellent oral and written communication skills.
• Ability to maintain confidentiality of information and materials
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