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Regulatory Affairs Associate
Ref No.: 18-00293
Location: Washington, District of Columbia
Position Type:Right to Hire

Clinical Research-Regulatory Affairs Associate
Washington, DC


MUST:
3+years of Regulatory Affairs experience in the clinical research field
Experience developing CER's (Clinical Evaluation Reports)
Strong experience working with submissions to the FDA on medical device approvals

Knowledge of orthopedic devices and trends preferred
Must be able to remain calm under high stress environment.
Must be able to efficiently manage time and resources.
Ability to multi-task at an extremely high level.
Good organizational skills, detail oriented and strong communication skills
Superior, self-directed letter writing and communication skills.
Ability to create materials to prove that device will be safe and effective
Masters of Biomedical Engineering/Bioengineering preferred

DUTIES:
Will handle 510k Regulatory Submissions to the FDA on Medical Device submissions

Develop CER's for medical device trials
Handle Strategy, Analysis & Development of medical devices as it relates to preparation for FDA for approval
Prepare and develop materials to assist companies with market clearance of devices
Design, Review & Implement Pre-Clinical Testing
Other Projects
Putting scientific information together that will be satisfactory for FDA
Preparing information and documents
Experience working with submissions to the FDA on medical device approvals
Create materials to prove that device will be safe and effective
*Quadrant, Inc. is an equal opportunity and affirmative action employer. Quadrant is committed to administering all employment and personnel actions on the basis of merit and free of discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or status as an individual with a disability. Consistent with this commitment, we are dedicated to the employment and advancement of qualified minorities, women, individuals with disabilities, protected veterans, persons of all ethnic backgrounds and religions according to their abilities.