We deliver strategic workforce solutions that help you manage your talent and business more ... RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, desirable 4. ...
We deliver strategic workforce solutions that help you manage your talent and business more ... RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, desirable 4. ...
Regulatory Affairs Specialist
Fort Worth, TX · On-site
$75K - $90K/yr
Support integration of regulatory requirements into the Quality Management System (QMS ... RAC (Regulatory Affairs Certification) preferred. * Experience supporting promotional material ...
Regulatory Affairs Specialist
Fort Worth, TX · On-site
$75K - $90K/yr
Support integration of regulatory requirements into the Quality Management System (QMS ... RAC (Regulatory Affairs Certification) preferred. * Experience supporting promotional material ...
Senior Manager, Regulatory Affairs
Tampa, FL · On-site +1
RAC (Regulatory Affairs Certification). * Medical Device and/ or Pharmaceutical Industry experience ... Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality ...
Senior Manager, Regulatory Affairs
Tampa, FL · On-site +1
RAC (Regulatory Affairs Certification). * Medical Device and/ or Pharmaceutical Industry experience ... Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality ...
Senior Manager, Regulatory Affairs
Newark, NJ · On-site +1
RAC (Regulatory Affairs Certification). * Medical Device and/ or Pharmaceutical Industry experience ... Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality ...
Senior Manager, Regulatory Affairs
Newark, NJ · On-site +1
RAC (Regulatory Affairs Certification). * Medical Device and/ or Pharmaceutical Industry experience ... Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality ...
Senior Manager, Regulatory Affairs
New York, NY · On-site +1
RAC (Regulatory Affairs Certification). * Medical Device and/ or Pharmaceutical Industry experience ... Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality ...
Senior Manager, Regulatory Affairs
New York, NY · On-site +1
RAC (Regulatory Affairs Certification). * Medical Device and/ or Pharmaceutical Industry experience ... Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality ...
Senior Manager, Regulatory Affairs
Three Rivers, MI · On-site +1
RAC (Regulatory Affairs Certification). * Medical Device and/ or Pharmaceutical Industry experience ... Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality ...
Senior Manager, Regulatory Affairs
Three Rivers, MI · On-site +1
RAC (Regulatory Affairs Certification). * Medical Device and/ or Pharmaceutical Industry experience ... Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality ...
Senior Manager, Regulatory Affairs
New York, NY · On-site +1
RAC (Regulatory Affairs Certification). * Medical Device and/ or Pharmaceutical Industry experience ... Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality ...
Senior Manager, Regulatory Affairs
New York, NY · On-site +1
RAC (Regulatory Affairs Certification). * Medical Device and/ or Pharmaceutical Industry experience ... Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality ...
Senior Manager, Regulatory Affairs
Rochester, NY · On-site +1
RAC (Regulatory Affairs Certification). * Medical Device and/ or Pharmaceutical Industry experience ... Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality ...
Senior Manager, Regulatory Affairs
Rochester, NY · On-site +1
RAC (Regulatory Affairs Certification). * Medical Device and/ or Pharmaceutical Industry experience ... Project Team Members (PMT), Program Management Members (PMO), R&D/Product Support, Design Quality ...
RAC certification (Regulatory Affairs Certification). * Experience with electronic submission systems (e.g., eSTAR, EUDAMED). * Experience with MDSAP, ISO 14971 (risk management), and clinical ...
RAC certification (Regulatory Affairs Certification). * Experience with electronic submission systems (e.g., eSTAR, EUDAMED). * Experience with MDSAP, ISO 14971 (risk management), and clinical ...
Regulatory Affairs Specialist
Logan, UT · On-site
RAC certification (Regulatory Affairs Certification). * Experience with electronic submission systems (e.g., eSTAR, EUDAMED). * Experience with MDSAP, ISO 14971 (risk management), and clinical ...
Quick apply
Regulatory Affairs Specialist
Logan, UT · On-site
RAC certification (Regulatory Affairs Certification). * Experience with electronic submission systems (e.g., eSTAR, EUDAMED). * Experience with MDSAP, ISO 14971 (risk management), and clinical ...
Regulatory Affairs Specialist
$75K - $90K/yr
Support integration of regulatory requirements into the Quality Management System (QMS ... RAC (Regulatory Affairs Certification) preferred. * Experience supporting promotional material ...
Regulatory Affairs Specialist
$75K - $90K/yr
Support integration of regulatory requirements into the Quality Management System (QMS ... RAC (Regulatory Affairs Certification) preferred. * Experience supporting promotional material ...
Manage CAPA investigations, nonconformance reports, complaint files, and root cause analyses ... RAC (Regulatory Affairs Certification) or ASQ CQE/CQA certifications. * Experience with ...
Manage CAPA investigations, nonconformance reports, complaint files, and root cause analyses ... RAC (Regulatory Affairs Certification) or ASQ CQE/CQA certifications. * Experience with ...
Director, Regulatory Affairs & Quality Assurance
$150K - $198K/yr
Highly organized with strong project management capabilities. Preferred Qualifications * RAC (Regulatory Affairs Certification) and/or ASQ certifications (CQE, CQA). * Experience bringing products ...
Director, Regulatory Affairs & Quality Assurance
$150K - $198K/yr
Highly organized with strong project management capabilities. Preferred Qualifications * RAC (Regulatory Affairs Certification) and/or ASQ certifications (CQE, CQA). * Experience bringing products ...
Director, Regulatory Affairs & Quality Assurance
Middleton, WI · On-site
$150K - $198K/yr
Highly organized with strong project management capabilities. Preferred Qualifications * RAC (Regulatory Affairs Certification) and/or ASQ certifications (CQE, CQA). * Experience bringing products ...
Director, Regulatory Affairs & Quality Assurance
Middleton, WI · On-site
$150K - $198K/yr
Highly organized with strong project management capabilities. Preferred Qualifications * RAC (Regulatory Affairs Certification) and/or ASQ certifications (CQE, CQA). * Experience bringing products ...
Regulatory Affairs Specialist (FDA, DEA )
Irvine, CA · On-site
$60K - $76K/yr
Prepare and manage FDA submissions (e.g., drug listings, establishment registrations, 503A/503B ... Regulatory Affairs Certification (RAC) or DEA compliance training (preferred) * Experience ...
Regulatory Affairs Specialist (FDA, DEA )
Irvine, CA · On-site
$60K - $76K/yr
Prepare and manage FDA submissions (e.g., drug listings, establishment registrations, 503A/503B ... Regulatory Affairs Certification (RAC) or DEA compliance training (preferred) * Experience ...
Prepare and manage FDA submissions (e.g., drug listings, establishment registrations, 503A/503B ... Regulatory Affairs Certification (RAC) or DEA compliance training (preferred) * Experience ...
Prepare and manage FDA submissions (e.g., drug listings, establishment registrations, 503A/503B ... Regulatory Affairs Certification (RAC) or DEA compliance training (preferred) * Experience ...
Regulatory Affairs Manager
Largo, FL · On-site
Regulatory Affairs Certification (RAC) or equivalent professional certification. Responsibilities ... Manage interactions and negotiations with regulatory authorities to facilitate product approvals.
Regulatory Affairs Manager
Largo, FL · On-site
Regulatory Affairs Certification (RAC) or equivalent professional certification. Responsibilities ... Manage interactions and negotiations with regulatory authorities to facilitate product approvals.
Senior Regulatory Affairs Specialist
$100K - $150K/yr
Strong project management, communication, and technical writing skills Preferred * Regulatory Affairs Certification (RAC) * Experience with digital health or SaMD Equal Opportunity Employer/Veterans ...
Quick apply
Senior Regulatory Affairs Specialist
$100K - $150K/yr
Strong project management, communication, and technical writing skills Preferred * Regulatory Affairs Certification (RAC) * Experience with digital health or SaMD Equal Opportunity Employer/Veterans ...
Clinical SME I
Herndon, VA · Remote
RAC (Regulatory Affairs Certification) * Active clinical licensure preferred.
Quick apply
Clinical SME I
Herndon, VA · Remote
RAC (Regulatory Affairs Certification) * Active clinical licensure preferred.
Senior Regulatory Affairs Specialist
Dublin, CA · On-site
$100K - $150K/yr
Strong project management, communication, and technical writing skills Preferred * Regulatory Affairs Certification (RAC) * Experience with digital health or SaMD Equal Opportunity Employer/Veterans ...
Quick apply
Senior Regulatory Affairs Specialist
Dublin, CA · On-site
$100K - $150K/yr
Strong project management, communication, and technical writing skills Preferred * Regulatory Affairs Certification (RAC) * Experience with digital health or SaMD Equal Opportunity Employer/Veterans ...
Manager Rac Regulatory Affairs Certification information
See salary details
$28.85 - $34.09
4% of jobs
$34.09 - $39.34
19% of jobs
$40.65 is the 25th percentile. Wages below this are outliers.
$39.34 - $44.58
7% of jobs
$44.58 - $49.83
11% of jobs
The median wage is $53.88 / hr.
$49.83 - $55.07
12% of jobs
$55.07 - $60.31
15% of jobs
$64.12 is the 75th percentile. Wages above this are outliers.
$60.31 - $65.56
11% of jobs
$65.56 - $70.80
7% of jobs
$70.80 - $76.05
4% of jobs
$76.05 - $81.29
6% of jobs
$81.29 - $86.54
4% of jobs
$28
$56
$86
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Job 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.
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 desirableÂ
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)
About Integrated Resources
Sourced by ZipRecruiter
Integrated Resources Inc (IRI), based in Edison, NJ, US, is an esteemed player in the staffing solutions industry with a credible presence on their official website irionline.com. Notably, IRI provides a range of professional staffing services including contract, contract-to-hire, and direct hire solutions to a wide spectrum of industries such as healthcare, life sciences, manufacturing, financial, insurance, and others. Since its inception, IRI has been committed to delivering top-talent and optimum solutions to meet its clients' diverse needs.
Industry
Recruiting and staffing services
Company size
51 - 200 Employees
Headquarters location
Edison, NJ, US
Year founded
1996