Job Description
| REGULATORY AFFAIRS SPECIALIST Position Specific Requirements Responsible for internal domestic and international compliance activities working under the direction of the Regulatory Affairs Director Assists the Regulatory Affairs Director with regulatory strategyplans and requirements Prepares worldwide regulatory submissionsregistrations Participates in the review and disposition of labeling promotional materials and product modification Prepares documentation and coordinates activities related to PMAs 510ks and IDEs Supports engineering changes through RAQA practices by documentating the changes in compliance with Quality Systems Regulations (QSR) the Medical Device Directives CMDR and other International regulations Participates in cross functional departmental team projects and product development activitiesmeetings Provides support to RA Director for communication between Regulatory Agencies such as the Food and Drug Administration (FDA) and the European Notified Body Responsible for FDAISOMDDCMDR compliance documentation Assists in special projects as needed Contributes to team effort by accomplishing related duties as requested Qualifications Bachelors Degree in ScientificEngineering discipline A minimum of three years experience in a regulatory environment Willingness to handle a number of projects simultaneously in a fast paced environment Ability to assist in regulatory planning and strategies for domestic (510(k)IDEPMA) and international submissionsregistrations Ability to represent Regulatory Affairs to other departments Atrium Medical Corporation offers competitive salaries exceptional benefits and a business casual dress code We do not accept unsolicited Agency Resumes Atrium Medical Corporation is an equal opportunity employer dedicated to workforce diversity and a drug and smokefree environment Drug screening is required |
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