Regulatory Affairs Specialist

Integrated 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 Description Regulatory Affairs Specialist position: Exhibit competence in US & foreign government regulations regarding the manufacture & distribution of medical devices. Assist with activities necessary for the timely preparation, writing, and submission of international registrations (technical files), including all related amendments & supplements. EU experience with Dossiers and technical files is a plus. Prepare, write, and file regulatory documentation efficiently. Manage a significant amount of proprietary information with strict confidentiality. Possess strong project management skills. Have good oral communication skills for presentations and meetings. Work as a self-starter, effectively with minimal supervision. Demonstrate strong problem-solving and priority-setting abilities. Make informed decisions daily, based on regulatory expertise, government constraints, and business needs. Qualifications Education requirements: Bachelor's degree from an accredited college or university in science, biomedical engineering, medical/scientific writing, or public health administration. An advanced degree is desirable. Regulatory Affairs Certification (RAC) by the Regulatory Affairs Professional Society is desirable. Experience with foreign regulatory approval/clearance of medical devices, especially higher risk devices, is preferred. Typically 4-6 years of successful experience in regulatory activities that achieved domestic and international approvals. Additional Information Thank you! With regards, Sasha Sharma Clinical Recruiter Integrated Resources, Inc IT REHAB CLINICAL NURSING Direct: View phone number on click.appcast.io | (W) View phone number on click.appcast.io Inc. 5000 – 2007-2015 (9 Years in a row) #J-18808-Ljbffr