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 & fore.
Thanks!! With Regards,
Sasha Sharma
Clinical Recruiter
Integrated Resources, Inc
IT REHAB CLINICAL NURSING
Direct: 732-662-7964 | (W) 732-549-2030 x 219
Inc. 5000 – 2007-2015 (9 Years in a row)
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.