Job Title:Regulatory Specialist
Regulatory Specialist with exeperince in Medical device regulatory filings of
o Product transfer form NH to Contractor manufacture/Medtronic site
o Change notification for EU
o Technical File
o Domestic registration
? Must have knowledge of US FDA requirements of Class 1 & Class 2 medical devices.
? Developing and managing Certificates for Foreign Government (CFGs) for New and Legacy products
? Review Ad / Promotional materials based on product claims
? Lead 510K submission for applicable products and interface with the FDA
? Provide regulatory guidance during the development of new products.
? Review engineering changes to determine regulatory requirements.
? Lead fulfillment of periodic state licensing requirements.
? Review commercial releases
? Provide regulatory direction regarding clinical requirements and studies for new and legacy products.
? Provide Regulatory leadership and direction regarding the development of regulatory Clinical Evaluation Reports (CERs) inputs
? Lead or assist in internal Corrective Action Preventive Action (CAPA) activities.
? Support audits from agencies such as FDA, Notified Bodies, foreign governments, etc. as well as internal audits.
? Provide training to internal team members as business needs dictate.
? Able to exercise judgment independently and seek alignment when necessary.
? Utilize technical regulatory skills to propose strategies on complex issues.
? Evaluate regulatory risk and communicate those risks as well as providing potential solutions.
? Other regulatory / quality tasks as business needs dictate.
? Certification (such as RAC) or degree in Regulatory Affairs is a plus.
? Experience with medical devices involving electronics and/or software is a plus.
? 510(k) experiencepreferred