PRE MARKET REG AFFAIRS MANAGER – MEDICAL DEVICE REG AFFAIRS EXPERIENCE INC FDA & 510K SUBMISSIONS EXPERIENCE REQUIRED

Ref: 3947D2

$150,000- $160,000                                                                                               Fully Remote

Our client, a leading specialist manufacturer, seeks a Pre Market Regulatory Affairs Manager to beresponsible for determining regulatory requirements that affect the company and its products and for the process of preparing submissions to US and international regulatory agencies. The Regulatory Affairs Manager is the liaison for communication with regulatory agencies and regulatory agency inspections. This position is responsible for initiating and supporting quality systems activities in all aspects of the business, including identification and implementation of continuous process improvement activities. Managing a small team, responsibilities include;

• Regulatory Submissions 
• Regulatory Support
• International Regulatory Affairs
• Regulatory Liaison
• Labeling
• Collaboration & Integration
• Other duties and projects, as assigned.
• Manage and provide leadership to regulatory specialists at varying levels.

You should have a Bachelor’s Degree in Engineering or Science with 6-12 years of experience in Regulatory Affairs with strong medical product development, preferably with active medical devices and some staff management experience. You must also have strong experience with FDA device regulations and 510K submissions in North America and preferably EU/Asia too.

So, if that sounds like you, then please send your details to our MD, David Symes FCA, at david@compliancerecruitment.com (Including a contact number &  email) however please note we cannot reply to all applications, so only successful applications will be contacted (although under no circumstances are your details ever passed on without your specific permission).