FierceBiotech and FiercePharma Jobs
Regulatory Affairs Compliance Associate - Elite Recruiting Services, Inc.
Jun 25
Location: San Diego, CACategories: All Categories
Website: http://www.elitestaffingsvc.com
Position Description
Regulatory Affairs Compliance Associate
Assist VP of Regulatory Affairs with all aspects of regulatory compliance for this Class II Medical Device environment. In this manufacturing environment, you will help in defining global regulatory requirements, review data submitted by team members, and prepare regulatory documentation for agency submissions.
Duties and Responsibilities:
• Obtain documentation from various departments for regulatory purposes and ensure the accuracy of all information.
• Participate in compliance activities; including but not limited to: FDA and Notified Body audits, internal audits, complaint issues and vendor audits.
• Prepare regulatory documentation such as device listings, certificates to foreign governments and medial device licensing outside the US.
• Preparation and submission of 510k’s
• Prepare responses to action letters and regulatory agency requests
• Prepare status reports, charts, summaries, graphs, and other materials as necessary
• Coordinate product testing and facility audits
• Participate in regulatory strategies to identify submission requirements to ensure registration and approval of products.
Requirements:
• 1-3 years medical device regulatory affairs experience
• Strong written and verbal communication skills
• Must be highly organized, deadline driven, and have strong software skills in spreadsheets, word processing and databases.
