- Prepare Technical Documentation in satisfaction of EU MDR 2017/745 requirements.
- Administer regulatory documentation.
- Communicate International requirements to Iridex team.
- 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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Regulatory Affairs Associate - Los Angeles, United States - Apex Systems
Description
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.
MAJOR DUTIES AND RESPONSIBILITIES:
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.o Maintain regulatory files/database and chronologies.
o Implement/oversee change control of updated documents.
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.