Description
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