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
eTeam Inc – “ACCELERATED HIRES”
Efficiency, Synergy, Expertise
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
eTeam was formed in 1999 with the goal of becoming the supplier of choice for clients, employees and contingent workers. Today, we’re one of the fastest-growing companies in New Jersey and ranked as one of the best companies to work for by Staffing Industry Analysts and New Jersey Business. We’re also an honored member of Deloitte’s Technology Fast 50
- Locations
- Cincinnati, Ohio, United States
- Education
- bachelor degree
- Experience
- 4+ years