Position Responsibilities:
* Drive global regulatory strategy
* Represent Regulatory team in inter-departmental matters
* Ensure that effective regulatory strategies are developed and implemented for new and modified devices to assure timely approval/market clearance/registrations, in support of corporate goals and objectives
* Communicate with domestic and international regulatory agencies
* Establish project priorities to meet business objectives
* Advise team of prevailing and evolving global regulatory requirements and environment
* Develop, implement, and maintain policies and procedures
* Foster employee career development
Required Skills
* Extensive background in and knowledge of the development of regulatory submissions and documentation
* Strong strategic, decision?making, and risk assessment abilities
* Highly developed written and oral communication skills
* Excellent organizational, leadership, and interpersonal skills
Required Experience
* 510(k) or PMA submission experience
* 7+ years Regulatory Affairs medical device industry experience
* Bachelors degree required; advanced degree preferred
To find out more about Real please visit
www.realstaffing.com