Regulatory Affairs Manager

Medical Devices

A medical device manufacturing company located in the Boston area has an urgent need for a Regulatory Affairs professional with experience in 510k preparation and submissions, complaint handling, labeling, adverse event reports, and general regulatory affairs issues in the medical device industry.

This is a strong and growing company with excellent promotability and benefits. This position carries the responsibility for the regulatory functions within the facility.

Experience with European (EU) and Canadian submissions is a big plus.

Prior history of successful submittals and 510k preparations is also a big plus

Additionally, you have the opportunity to be a part of the product development team working with engineering and quality professionals to insure products in the pipeline are in compliance with applicable regulatory requirements.

QUALIFICATIONS

• 2+ years experience in Regulatory Affairs of medical devices 
• BS/BA minimum. Advanced degrees are a plus
• Broad knowledge of regulatory regulations and standards

There is a relocation package available for the right candidate.

Please respond to this advertisement by attaching your resume in Word format (.doc or .rtf) to an email addressed to john@mriatl.com and John Boynton at MRI Atlanta Peachtree North will give you a call if you meet the requirements.

I am building a network of talented people in the medical industry using Linkedin. This is an extremely helpful tool for networking and I hope you will send a link to join my network.