Regulatory Specialist

  •  

North Haven, CT

Industry: Healthcare

  •  

Not Specified years

Posted 171 days ago

  by    Bajrang Yadav

This job is no longer available.

Job Title:Regulatory Specialist

Location: US-IN

 

Overview:

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.

 

Primary Skills:

 

Secondary Skills:

? 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

 

Educational Qualifications