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 submissions in Europe (EU), Japan, Australia, Canada, and/or other countries is a big plus.

Prior history of successful 510k preparations and submittals is requirement.

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

• 5+ 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.