Regulatory Affairs Specialist

integratedresourcesinc
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📍 Salt Lake City📍 Salt Lake City, UT, United States📍 UT📍 usContract

About this role

Company Description

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 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

Qualifications

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.

Additional Information

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)

Frequently Asked Questions

Is the salary disclosed for the Regulatory Affairs Specialist position at integratedresourcesinc?
The salary for this Regulatory Affairs Specialist role at integratedresourcesinc is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the Regulatory Affairs Specialist position at integratedresourcesinc located?
This Regulatory Affairs Specialist role at integratedresourcesinc is based in Salt Lake City, Salt Lake City, UT, United States, UT, us. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the Regulatory Affairs Specialist role at integratedresourcesinc full-time or part-time?
This is listed as a Contract position. It is posted as a Regulatory Affairs Specialist role at integratedresourcesinc.
How do I apply for the Regulatory Affairs Specialist position at integratedresourcesinc?
Click the "Apply Now" button on this page. You will be redirected to integratedresourcesinc's official application portal hosted on smartrecruiters where you can submit your application directly.
When was the Regulatory Affairs Specialist job at integratedresourcesinc posted?
This Regulatory Affairs Specialist position at integratedresourcesinc was posted on Jul 11, 2017. Apply as soon as possible — early applications are often reviewed first.
Regulatory Affairs Specialist
integratedresourcesinc
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