REGULATORY AFFAIRS ASSOCIATE
JOB PURPOSE
The Regulatory Affairs Associate is responsible for the testing of new products to support regulatory clearance activities.
KEY DUTIES & RESPONSIBILITIES
- Perform new product validation studies that are required for Design History Files and submissions to national and international regulatory bodies
- Organize and maintain data generated from new product testing
- Assist in maintaining Design History Files, Technical Files and other regulatory documents
- Assist in preparing regulatory submission documents
- Other duties, as assigned
QUALIFICATIONS
- Bachelor’s degree in science or combination of other education/job related experience
- Extremely organized with high attention to detail
- Effective written and oral communication skills
- Effective at multi-tasking
- Ability to work in a fast-paced, timeline-driven environment
- Ability to work independently and as part of a team
- Experience in medical devices a plus
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