Senior Regulatory Affairs Specialist
5 - 7 years experience • Medical Devices & Diagnostics
Responsible for the implementation and administration of organization activities to support and ensure regulatory compliance.
Prepare PMA and PMA supplements for regulatory approval of Class Ill device in US.
Prepare 510(k) submission for regulatory approval of Class II devices in US. Prepare Medical Device License Applications/Amendments for regulatory approval in Canada.
Prepare and support Shonin applications for regulatory approval in Japan. Prepare and maintain product Technical Files in accordance with Medical Device Directive (MOD)
Conduct review of product and manufacturing changes for compliance with applicable regulations (Change Control).
In conjunction with Clinical Affairs, support the preparation of applications (i.e., Pre lDE, IDE, supplements) for conducting clinical investigations in U.S.
Supportinternational product registrations
Provide input in developing regulatory strategy for global regulatory plans. Provide guidance and review product labeling, promotional material, and other related product documentation.
Mentor and train Regulatory Affairs Specialists/Coordinators on U.S. and International submissions and requirements as well as company's regulatory policies and practices
Represent Regulatory Affairs in multi-discipline product development teams.
Ensure that all work activity is performed in accordance with established procedures and regulatory requirements
Identify corrective actions and process improvements. Participate as an auditor in internal audit activities
Support Health Hazard Assessments and Field Actions as needed. Other duties as assigned
Excellent oral and written communication skills Excellent organizational skills
Knowledge of FDA, European, Canadian and Japanese Regulatory Requirements
Required/ PreferredEducation and Experience:
Four year college degree with 6+ years related experience or a Master's Degree with 4+ years related experience in a medical device regulatory capacity; experience with defibrillation, pacing and resuscitation devices strongly preferred
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities will be reviewed periodically as duties and responsibilities change with business necessity. Essential and marginal job functions are subject to modification.
ADA: The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990