Regulatory Affairs Manager III

Job Description

• Exhibit 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:
  
  Bachelor degree from accredited college or university in science, biomedical engineering, medical/scientific writing, public health administration
• Advanced degree is desirable
• RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, desirable
• 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