Medical Device Regulatory Specialist

Medical Device - Manufacturing Regulatory Affairs Specialist

Position Summary:

The Regulatory Affairs Specialist will be responsible for company organizational goals that are effective and in compliance by providing expertise and guidance regarding domestic and international regulatory and quality requirements needed to meet product development projects, complaints, adverse reactions/events.

This Regulatory Affairs Specialist duties will include:

• Document preparation, performance metrics and review of certain controlled documents
• Develop, implement, and maintain procedures in support of regulatory compliance
• Assist with the development and implementation of regulatory strategies for existing, new, and modified products

Required Qualifications:

• 5-7 years' regulatory/quality experience in an FDA/EU regulated industry re: medical device - manufacturing
• 3 years' supervisory experience in this environment of regulatory and product development
• Previous experience preparing and submitting regulatory product submissions

Demonstrating leadership skills as a Regulatory Affairs Specialist using methods including workflow, layout, assembly, and production equipment. With a team player mentality to motivate, address, and compromise. Using these skills to problems solving with attention to detail. A Regulatory Specialist will implement lean Six Sigma programs for benchmark safety.

Up to $110K/year DEO

Great Benefits - Apply Today

All qualified applicants will receive consideration without regard to race, age, color, sex (including pregnancy), religion, national origin, disability, sexual orientation, gender identity, marital status, military status, genetic information, or any other status protected by applicable laws or regulations.

GPAC (Growing People and Companies) is an award-winning search firm specializing in placing quality professionals within multiple industries across the United States for the past 31 years. We are extremely competitive, client-focused and realize that our value is in our ability to deliver the right solutions at the right time.