Regulatory Affairs Specialist

Regulatory Affairs Specialist position:
• Exhibit a competence in US & foreign government regulations regarding the manufacture & distribution of medical devices
• Assist with activities necessary for the timely preparation, writing & submitting of international registrations (technical files), & all related amendments & supplements. EU experience with Dossiers and technical files a plus
• Exhibit competence in preparing, writing & filing regulatory documentation
• Manage a significant amount of proprietary information in an extremely confidential manner
• Possess strong project management skills
• Possess good oral communication skills -presentation & meeting interactions
• Work as a self-starter - work effectively with some supervision
• Possess strong problem-solving & priority setting
• Exhibit strong decision making - numerous independent decisions every day & must therefore have the ability & confidence to effect informed decisions based upon regulatory expertise, government constraints, & a thorough understanding of business needs