Regulatory Affairs Manager III

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

Education requirements: 1. Bachelor degree from accredited college or university in science, biomedical engineering, medical / scientific writing, public health administration 2. Advanced degree is desirable 3. RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, desirable 4. Evidence of foreign regulatory approval / clearance of new or modified medical devices; experience with higher risk device desirable 4-6 years of successful experience conducting regulatory activities that achieved domestic & foreign regulatory

Thanks & Regards

Neha Sharma

Lead Recruiter

eTeam Inc – “ACCELERATED HIRES”

Efficiency, Synergy, Expertise

T-732-248-1900 .Ext 120

Awards

#1 Best Places to work in New Jersey-2009,2008,2007,2006

Top Small Diversity Business, 2006 by DiversityBusiness.com

Deloitte Technology Fast 500-2007,2006

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