Description
Position Responsibilities* Write and manage US regulatory submissions including original IDE, PMA, and 510(k) submissions and supplements/amendments
* Write and manage CE Marking submissions
* Collaborate with global RA partners to develop global filing strategies and support global submissions
* Provide regulatory affairs support for all aspects of product development from early research to commercialization
* Collaborate with European RA team to provide regulatory support for all aspects of product manufacturing
Basic Qualifications
* Bachelor's degree in a technical discipline.
* 2-4 Years of regulatory experience with Bachelors, 1-3 Years with Masters
* Knowledge of FDA medical device regulations and experience with Class II or III devices. Desired/Preferred Qualifications
* Knowledge of and experience with IEC nd and/or 3rd editions
* Knowledge of electro-medical regulations
* Experience with hardware/software requirements
* US and/or EU experience registering electro-medical devices
* Ability to manage an activity involving a global, cross-functional team within a large international corporate organization.
* Excellent negotiation skills; written/oral communication skills.
* Knowledge of and experience with IEC nd and/or 3rd editions
* Knowledge of European medical device regulations and experience working with European regulators.
* History of successful 510(k)/IDE/PMA/CE mark submissions.
* Previous involvement in global regulatory activities
* Experience with regulatory support of clinical trials.
To find out more about Real please visit www.realstaffing.com