Description

• Contract position for a Regulatory Associate for medical device manufacturing.
• Assist in the development and control of medical device regulatory documents and reports for management.
• Organize quality, regulatory and design history files compliant with ISO 9000, ISO 13485, European and USA Federal requirements.
• Report in-house and field quality data from customers.
• Assist in conducting internal quality audits on a scheduled basis.

Requirements

• Associate's Degree in Business or equivalent.
• Training in business writing and report generation, preferred, but will train the right person.
• Minimum 1-2 years experience in an ISO 9000 or ISO 13485 environment.
• Experience as an administrative assistant or record keeper position.
• Excellent verbal and written communication skills.
• Intermediate-level Microsoft Office experience with Excel and Word.
• #ERGx