The Regulatory Affairs Specialist, reporting to the Regulatory Affairs Director, will help develop, implement and maintain the Regulatory Processes within the Quality Management System (QMS), including creation and maintenance of the documentation associated with filing for high risk medical device for the US and OUS submissions.

RESPONSIBILITIES:

• Assist with the development and implementation of regulatory procedures
• Operate as the primary contact for regulatory submissions, including, but not limited to, pre-submission meetings and marketing applications.
• Act as primary author and project representative for FDA IDE, 510(k), PMA submissions and EU Technical Files.
• Take on assignments from project core teams and support other initiatives on a departmental basis.
• Maintain marketing authorizations and approvals through change management and, if necessary, drafting and submission of supplements or change notifications to regulatory authorities.
• Review of the documentation associated with the support and continued manufacturing for Companion Diagnostics.
• Perform other duties as assigned by supervisor

QUALIFICATIONS:

• High degree of proficiency with MS Office and Adobe PDF creation.
• Demonstrable, hands-on experience with substantial medical, technical or regulatory writing. A writing sample is welcome.
• Experience writing FDA marketing applications (e.g. PMA, de novo 510(k)) for IVD or medical device products, acting as the primary submission author.
• Two (2) or more years of regulatory affairs experience in medical devices.
• Experience with quality systems in regulated space preferred, with responsibility for generating new documents and conducting team reviews.
• Ability to interact with multiple disciplines, and communicate clearly and effectively verbally and in writing.
• Ability to work independently, and utilize good problem-solving skills
• Ability to multitask and work within a fast-paced dynamic team environment

EDUCATION: