Full-Time
Regulatory Affairs Specialist
Integrated Resources
501-1,000 employees
No salary listed
Salt Lake City, UT, USA
In Person
 Legal & Compliance (1) |
|---|
- Bachelor degree from accredited college or university in science, biomedical engineering, medical / scientific writing, public health administration
- 4-6 years of successful experience conducting regulatory activities that achieved domestic and foreign regulatory approvals
- Exhibit a competence in US and foreign government regulations regarding the manufacture and distribution of medical devices
- Assist with activities necessary for the timely preparation, writing and submitting of international registrations (technical files), and all related amendments and supplements
- Exhibit competence in preparing, writing and 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 and meeting interactions
- Work as a self-starter - work effectively with some supervision
- Possess strong problem-solving and priority setting
- Exhibit strong decision making - numerous independent decisions every day and must therefore have the ability and confidence to effect informed decisions based upon regulatory expertise, government constraints, and a thorough understanding of business needs
- Advanced degree is desirable
- Regulatory Affairs Certification (RAC) by Regulatory Affairs Professional Society, desirable
- Evidence of foreign regulatory approval / clearance of new or modified medical devices; experience with higher risk device desirable
- EU experience with Dossiers and technical files a plus
Company Size
501-1,000
Company Stage
N/A
Total Funding
N/A
Headquarters
Edison, New Jersey
Founded
1996
Simplify's Take
What believers are saying
- Certification boosts appeal to quality-focused healthcare organizations.
- Reskilling programs cut time-to-hire amid workforce shortages.
- Positions IRI among 15,000 Joint Commission-accredited elite firms.
What critics are saying
- Certification lapses in 12-18 months from failed onsite review.
- Patient complaints trigger decertification and client losses in 6-12 months.
- AMN Healthcare captures IRI's mid-sized clients in 12-24 months.
What makes Integrated Resources unique
- Joint Commission Gold Seal certifies IRI's staffing compliance since 2009.
- AI tool Nova hybridizes with reskilling to close healthcare skills gaps.
- Focuses on diversity hiring and performance monitoring for elite placements.
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Benefits
Wellness Program
Mental Health Support
Flexible Work Hours
Phone/Internet Stipend
Home Office Stipend
Conference Attendance Budget
Company News
Edison, New Jersey - Integrated Resources Inc. has earned The Joint Commission's Gold Seal of Approval(R) for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.
Integrated Resources Inc. has earned The Joint Commission’s Gold Seal of Approval ® for Health Care Staffing Services Certification by demonstrating continuous compliance with its performance standards.