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Device Regulatory Affairs Manager

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POST DATE 9/6/2016
END DATE 11/5/2016

Medpace, Inc. Blaine, MN

Company
Medpace, Inc.
Job Classification
Full Time
Company Ref #
290551332-1259
Location
Blaine, MN
Job Type
Regular
AJE Ref #
576101358

JOB DESCRIPTION

POSITION SUMMARY



Medpace is a global, full-service Clinical Research Organization (CRO) specializing in a multitude of therapeutic areas. Our headquarters are located in Cincinnati, Ohio and we are active in over 40 countries across the globe. We continue to steadily grow and are looking to add to our device team.



We are currently seeking a full-time, office-based Regulatory Affairs Manager to join our medical device team in Blaine, MN. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.



DESCRIPTION OF JOB DUTIES





* Track, compile, and maintain full regulatory applications;

* Maintain timelines for full regulatory documents;

* Provide regulatory advice and guidance to MMD to ensure compliance with appropriate national/regional government regulations and requirements (including review of protocols, drug development plans, study reports, and marketing application components);

* Interact with appropriate national/regional government regulatory agencies; and

* Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.

* Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges; and

* Coordinate interactions and timelines with outside vendors regarding regulatory documents.





QUALIFICATIONS/REQUIREMENTS





* Master's degree or equivalent and 5 years regulatory affairs experience or Bachelor's degree or equivalent and 7 years regulatory affairs experience;

* Demonstrate ability to independently track, compile, and maintain full regulatory applications to ensure compliance with governing regulations and guidance;

* Demonstrate ability to interact with appropriate national/regional government regulatory agencies; and

* Demonstrate ability to write departmental Standard Operating Procedures.



WHY MEDPACE?



At Medpace, you will find work that is both challenging and rewarding. At Medpace, you will be given the tools and training to succeed. At Medpace, you will be rewarded for strong performance and provided opportunities to grow professionally.



WHAT TO EXPECT NEXT



We look forward to receiving your application. A member of our recruitment team will review your qualifications. If interested, you will be contacted for an interview.



EO/AA Employer M/F/Disability/Vets