Regulatory Affairs Specialist

Regulatory Affairs SpecialistIntegrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.Job DescriptionRegulatory 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 needsQualificationsEducation 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 & fore