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

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