Required: (Remote Opportunity - Temp to Perm) The Regulatory Affairs Manager ensures compliance to ... Preparing international regulatory submissions and FDA submissions which may include device 510(k ...
Required: (Remote Opportunity - Temp to Perm) The Regulatory Affairs Manager ensures compliance to ... Preparing international regulatory submissions and FDA submissions which may include device 510(k ...
Temporary Clinical Research Regulatory Coordinator
Orange, CA · On-site
$37.56/hr
Medical
Retirement
PTO
Demonstrated knowledge of FDA regulations, Good Clinical Practice (GCP), IRB processes, and ... Certain temporary assignments may require clearance of a health physical or require a valid ...
Temporary Clinical Research Regulatory Coordinator
Orange, CA · On-site
$37.56/hr
Medical
Retirement
PTO
Demonstrated knowledge of FDA regulations, Good Clinical Practice (GCP), IRB processes, and ... Certain temporary assignments may require clearance of a health physical or require a valid ...
Temporary Clinical Research Regulatory Coordinator
Orange, CA · On-site
$37.56/hr
Medical
Retirement
PTO
Demonstrated knowledge of FDA regulations, Good Clinical Practice (GCP), IRB processes, and ... The majority of our temporary positions are Monday - Friday, 8:00 a.m. - 5:00 p.m. We also have ...
Temporary Clinical Research Regulatory Coordinator
Orange, CA · On-site
$37.56/hr
Medical
Retirement
PTO
Demonstrated knowledge of FDA regulations, Good Clinical Practice (GCP), IRB processes, and ... The majority of our temporary positions are Monday - Friday, 8:00 a.m. - 5:00 p.m. We also have ...
Regulatory Coordinator
Bohemia, NY · On-site
$65K - $70K/yr
Medical
Dental
Vision
Retirement
... FDA, FTC, and other regulatory requirements. The ideal candidate will have hands-on experience ... Work through regulatory changes, temporary deviations, and permanent product modifications, and ...
Regulatory Coordinator
Bohemia, NY · On-site
$65K - $70K/yr
Medical
Dental
Vision
Retirement
... FDA, FTC, and other regulatory requirements. The ideal candidate will have hands-on experience ... Work through regulatory changes, temporary deviations, and permanent product modifications, and ...
Central North Carolina (Triangle Region) Job Type: Part-Time, Temporary Headquarters: New ... This position plays a critical role in supporting federal and state regulatory enforcement by ...
Quick apply
Central North Carolina (Triangle Region) Job Type: Part-Time, Temporary Headquarters: New ... This position plays a critical role in supporting federal and state regulatory enforcement by ...
Central North Carolina (Triangle Region) Job Type: Part-Time, Temporary Headquarters: New ... This position plays a critical role in supporting federal and state regulatory enforcement by ...
Central North Carolina (Triangle Region) Job Type: Part-Time, Temporary Headquarters: New ... This position plays a critical role in supporting federal and state regulatory enforcement by ...
Regulatory Specialist
Erlanger, KY · On-site
$72K - $83K/yr
Medical
Dental
Vision
Retirement
... FDA and international guidelines), exceptional organizational discipline, and the ability to ... For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major ...
Regulatory Specialist
Erlanger, KY · On-site
$72K - $83K/yr
Medical
Dental
Vision
Retirement
... FDA and international guidelines), exceptional organizational discipline, and the ability to ... For temporary assignments lasting 13 weeks or longer, AllSTEM Connections is pleased to offer major ...
Senior Regulatory Writer (Temporary)
$130 - $170/hr
THE OPPORTUNITY Vir Biotechnology is looking for a Senior Regulatory Writer (Temporary) who will ... FDA and EMA * Write and edit a wide range of regulatory documents, including but not limited to:
Senior Regulatory Writer (Temporary)
$130 - $170/hr
THE OPPORTUNITY Vir Biotechnology is looking for a Senior Regulatory Writer (Temporary) who will ... FDA and EMA * Write and edit a wide range of regulatory documents, including but not limited to:
Senior Regulatory Affairs Specialist
Mason, OH · On-site
Medical
Dental
Retirement
AtriCure's cryoICE cryoSPHERE ® probe is cleared for temporary ablation of peripheral nerves to ... Supports inspections and audits by FDA, notified body, and other regulatory agencies * Monitor and ...
Senior Regulatory Affairs Specialist
Mason, OH · On-site
Medical
Dental
Retirement
AtriCure's cryoICE cryoSPHERE ® probe is cleared for temporary ablation of peripheral nerves to ... Supports inspections and audits by FDA, notified body, and other regulatory agencies * Monitor and ...
Senior Regulatory Affairs Specialist
Mason, OH · On-site
$106 - $130/hr
Medical
Dental
Retirement
AtriCure's cryoICE cryoSPHERE ® probe is cleared for temporary ablation of peripheral nerves to ... Supports inspections and audits by FDA, notified body, and other regulatory agencies * Monitor and ...
Senior Regulatory Affairs Specialist
Mason, OH · On-site
$106 - $130/hr
Medical
Dental
Retirement
AtriCure's cryoICE cryoSPHERE ® probe is cleared for temporary ablation of peripheral nerves to ... Supports inspections and audits by FDA, notified body, and other regulatory agencies * Monitor and ...
Regulatory Analyst 1 - Remote
Miami, FL · On-site +1
Medical
Dental
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click ... Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH ...
Regulatory Analyst 1 - Remote
Miami, FL · On-site +1
Medical
Dental
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click ... Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH ...
Regulatory Analyst 1 - Remote
Miami, FL · On-site +1
Medical
Dental
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click ... Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH ...
Regulatory Analyst 1 - Remote
Miami, FL · On-site +1
Medical
Dental
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click ... Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH ...
Regulatory Analyst 1 - Remote
Miami, FL · On-site +1
Medical
Dental
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click ... Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH ...
Regulatory Analyst 1 - Remote
Miami, FL · On-site +1
Medical
Dental
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click ... Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH ...
Regulatory Analyst 1 - Remote
Miami, FL · On-site +1
Medical
Dental
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click ... Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH ...
Regulatory Analyst 1 - Remote
Miami, FL · On-site +1
Medical
Dental
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click ... Ensures compliance of general and study specific regulatory related processes with SOPs, FDA, NIH ...
Principal Regulatory Writer (Temporary)
$180 - $200/hr
THE OPPORTUNITY Vir Biotechnology is looking for a Principal Regulatory Writer (Temporary) who will ... FDA and EMA * Write and edit a wide range of regulatory documents, including but not limited to:
Principal Regulatory Writer (Temporary)
$180 - $200/hr
THE OPPORTUNITY Vir Biotechnology is looking for a Principal Regulatory Writer (Temporary) who will ... FDA and EMA * Write and edit a wide range of regulatory documents, including but not limited to:
Regulatory Specialist
Erlanger, KY · On-site
$70K - $81K/yr
Medical
Dental
Vision
Retirement
Contract/Temporary. - Location: Erlanger, KY. Equal Opportunity Employer / Disabled / Protected ... with FDA and Canadian regulations. - Strong computer skills, including proficiency with Microsoft ...
Regulatory Specialist
Erlanger, KY · On-site
$70K - $81K/yr
Medical
Dental
Vision
Retirement
Contract/Temporary. - Location: Erlanger, KY. Equal Opportunity Employer / Disabled / Protected ... with FDA and Canadian regulations. - Strong computer skills, including proficiency with Microsoft ...
Regulatory Compliance Manager
Wheeling, IL · On-site
Medical
Dental
Vision
Life
Retirement
PTO
... temporary approvals as applicable. * Review formulas, raw materials, supplier documentation ... Proficient knowledge of FALCPA, FDA labeling requirements, USDA and FSIS regulations, nutrition ...
Regulatory Compliance Manager
Wheeling, IL · On-site
Medical
Dental
Vision
Life
Retirement
PTO
... temporary approvals as applicable. * Review formulas, raw materials, supplier documentation ... Proficient knowledge of FALCPA, FDA labeling requirements, USDA and FSIS regulations, nutrition ...
Regulatory Compliance Manager
Wheeling, IL · On-site
$95K - $120K/yr
Medical
Dental
Vision
Life
Retirement
PTO
... temporary approvals as applicable. * Review formulas, raw materials, supplier documentation ... Proficient knowledge of FALCPA, FDA labeling requirements, USDA and FSIS regulations, nutrition ...
Regulatory Compliance Manager
Wheeling, IL · On-site
$95K - $120K/yr
Medical
Dental
Vision
Life
Retirement
PTO
... temporary approvals as applicable. * Review formulas, raw materials, supplier documentation ... Proficient knowledge of FALCPA, FDA labeling requirements, USDA and FSIS regulations, nutrition ...
Clinical Research Associate (CRA) - Temporary Location: Waltham, MA Schedule: Flexible hours, about ... guidelines, FDA regulations, and company standards. * Manage assigned operational aspects of ...
Clinical Research Associate (CRA) - Temporary Location: Waltham, MA Schedule: Flexible hours, about ... guidelines, FDA regulations, and company standards. * Manage assigned operational aspects of ...
Clinical Research Associate (CRA) - Temporary Location: Waltham, MA Schedule: Flexible hours, about ... guidelines, FDA regulations, and company standards. * Manage assigned operational aspects of ...
Quick apply
Clinical Research Associate (CRA) - Temporary Location: Waltham, MA Schedule: Flexible hours, about ... guidelines, FDA regulations, and company standards. * Manage assigned operational aspects of ...
Temporary Fda Regulatory information
See salary details
$18.99 - $22.95
3% of jobs
$22.95 - $26.90
6% of jobs
$26.90 - $30.86
13% of jobs
$31.38 is the 25th percentile. Wages below this are outliers.
$30.86 - $34.81
20% of jobs
The median wage is $36.35 / hr.
$34.81 - $38.77
19% of jobs
$38.77 - $42.72
9% of jobs
$44.70 is the 75th percentile. Wages above this are outliers.
$42.72 - $46.68
10% of jobs
$46.68 - $50.63
6% of jobs
$50.63 - $54.59
5% of jobs
$54.59 - $58.54
5% of jobs
$58.54 - $62.50
3% of jobs
$18
$39
$62
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Temporary
Re-posted 9 days ago
Job description
Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs.
Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence.
Required: (Remote Opportunity - Temp to Perm)
The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.
In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth.
The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements.
Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters.
Key responsibilities:
Lead Regulatory Associates or Specialists in addition to work as an individual contributor
Prepare, review and file FDA premarket submission to ensure devices are commercially available in the U.S.: pre-IDEs, IDEs, 510(k)s, PMAs and PMA Supplements. (Will also be involved in EU submissions)
Represent RA as core team member to drive innovation on Tech. Dev. Projects and follow through to market release.
Develop Regulatory Strategies for new or modified products and prepare project plans & budgets.
Monitor and provide management with impact of changes in the Regulatory environment.
Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management.
Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators.
Support Design Control process.
Prepare Rational to file documentation for modifications to devices when appropriate.
Participate in FDA & other notified body Inspections.
Author and/or review regulatory procedures and update as necessary.
Review change control documents and ascertain Regulatory impact for external and internal documents.
Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information.
Review promotional material and labeling for regulatory compliance.
Required qualifications:(Remote Opportunity)
Bachelor's degree required. Scientific or engineering field preferred.
5+ years of medical device regulatory affairs experience.
Must have authored 510(k) submissions
Must have knowledge of U.S. FDA regulations and standards
3+ years of experience interacting with FDA and/or other regulatory agencies
Experience with devices containing software is strongly preferred.
Must work well in team environments
Must demonstrate leadership skills in team setting.
Proven analytical abilities
Solid understanding of manufacturing and change control, and an awareness of regulatory trends
To know more on this position or to schedule an interview, please contact;
Ujjwal Mane
973-805-7557
ujjwal.mane[@]collabera.com