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 ...
QA Auditor (FDA/GMP/21 CFR)
Lancaster, SC · On-site
Full relocation package available (including temporary housing, moving/storage, and paid site ... Support regulatory inspection readiness and internal training initiatives * Travel to supplier ...
QA Auditor (FDA/GMP/21 CFR)
Lancaster, SC · On-site
Full relocation package available (including temporary housing, moving/storage, and paid site ... Support regulatory inspection readiness and internal training initiatives * Travel to supplier ...
Regulatory Coordinator
Bohemia, NY · On-site
$65K - $70K/yr
... 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
... 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 ...
Ensure compliance with FDA Quality Management System Regulations for medical devices and Canadian ... Responsible for sign-off of engineering change orders, rework authorizations, temporary deviations ...
Quick apply
Ensure compliance with FDA Quality Management System Regulations for medical devices and Canadian ... Responsible for sign-off of engineering change orders, rework authorizations, temporary deviations ...
Ensure compliance with FDA Quality Management System Regulations for medical devices and Canadian ... Responsible for sign-off of engineering change orders, rework authorizations, temporary deviations ...
Ensure compliance with FDA Quality Management System Regulations for medical devices and Canadian ... Responsible for sign-off of engineering change orders, rework authorizations, temporary deviations ...
Ensure compliance with FDA Quality Management System Regulations for medical devices and Canadian ... Responsible for sign-off of engineering change orders, rework authorizations, temporary deviations ...
Ensure compliance with FDA Quality Management System Regulations for medical devices and Canadian ... Responsible for sign-off of engineering change orders, rework authorizations, temporary deviations ...
This position has a Temporary Duty (TDY) or business travel requirement of 15% of the time ... FDA) regulated research and development efforts. 2. Experience providing regulatory affairs ...
This position has a Temporary Duty (TDY) or business travel requirement of 15% of the time ... FDA) regulated research and development efforts. 2. Experience providing regulatory affairs ...
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 Affaris Specialist - Temporary
Irvine, CA · On-site
$45 - $50/hr
Knowledge of FDA, and CE marking requirements for IVD products is a plus * Able to work ... TEMPORARY
Regulatory Affaris Specialist - Temporary
Irvine, CA · On-site
$45 - $50/hr
Knowledge of FDA, and CE marking requirements for IVD products is a plus * Able to work ... TEMPORARY
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 ...
Regulatory Affaris Specialist - Temporary
Irvine, CA · On-site
$45 - $50/hr
Knowledge of FDA, and CE marking requirements for IVD products is a plus * Able to work ... As a temporary associate, your employment will be managed directly through our approved agency ...
Regulatory Affaris Specialist - Temporary
Irvine, CA · On-site
$45 - $50/hr
Knowledge of FDA, and CE marking requirements for IVD products is a plus * Able to work ... As a temporary associate, your employment will be managed directly through our approved agency ...
Interface with health authorities, particularly the FDA, to support regulatory interactions ... If eligible, the benefits available for this temporary role may include the following: • Medical ...
Quick apply
Interface with health authorities, particularly the FDA, to support regulatory interactions ... If eligible, the benefits available for this temporary role may include the following: • Medical ...
Sr. Manager CMC Regulatory
Morristown, NJ · On-site
$140K - $165K/yr
Critically review documentation intended for submission to the FDA for internal consistency and ... If eligible, the benefits available for this temporary role may include the following: • Medical ...
Quick apply
Sr. Manager CMC Regulatory
Morristown, NJ · On-site
$140K - $165K/yr
Critically review documentation intended for submission to the FDA for internal consistency and ... If eligible, the benefits available for this temporary role may include the following: • Medical ...
Senior Manager Of CMC Regulatory
$140K - $165K/yr
Deep understanding of pharmaceutical development, CMC regulatory frameworks, and FDA/ICH guidelines ... If eligible, the benefits available for this temporary role may include the following: • Medical ...
Quick apply
Senior Manager Of CMC Regulatory
$140K - $165K/yr
Deep understanding of pharmaceutical development, CMC regulatory frameworks, and FDA/ICH guidelines ... If eligible, the benefits available for this temporary role may include the following: • Medical ...
Operations Manager Clinical Trials
$41 - $56/hr
Temporary Contract (15 Weeks) Schedule: Monday - Friday | 8:30 AM - 5:00 PM Pay: $41.00 - $56.00 ... Ensure compliance with FDA regulations, Good Clinical Practice (GCP), IRB requirements, and sponsor ...
Quick apply
Operations Manager Clinical Trials
$41 - $56/hr
Temporary Contract (15 Weeks) Schedule: Monday - Friday | 8:30 AM - 5:00 PM Pay: $41.00 - $56.00 ... Ensure compliance with FDA regulations, Good Clinical Practice (GCP), IRB requirements, and sponsor ...
Packaging Operator I
Tampa, FL · On-site
$15 - $20/hr
Temporary Assignment Work Type: Onsite Shift: 07:00 AM to 03:30 PM Summary * Operate and tend ... Working knowledge of cGMP and FDA regulations * Strong attention to detail with accurate and timely ...
Quick apply
Packaging Operator I
Tampa, FL · On-site
$15 - $20/hr
Temporary Assignment Work Type: Onsite Shift: 07:00 AM to 03:30 PM Summary * Operate and tend ... Working knowledge of cGMP and FDA regulations * Strong attention to detail with accurate and timely ...
... limited to: - Temporary Staffing - Permanent Staffing - Payrolling - Recruitment Process ... Contact FDA and other Regulatory authorities for review status updates for pending applications and ...
... limited to: - Temporary Staffing - Permanent Staffing - Payrolling - Recruitment Process ... Contact FDA and other Regulatory authorities for review status updates for pending applications and ...
Packaging Operator I
Tampa, FL · On-site
$20 - $24/hr
Temporary Assignment Work Type: Onsite Shift: 3rd Shift Summary * Operate and tend packaging ... Working knowledge of cGMP and FDA regulations * Strong attention to detail with accurate and timely ...
Quick apply
Packaging Operator I
Tampa, FL · On-site
$20 - $24/hr
Temporary Assignment Work Type: Onsite Shift: 3rd Shift Summary * Operate and tend packaging ... Working knowledge of cGMP and FDA regulations * Strong attention to detail with accurate and timely ...
... FDA regulatory standards. They will manage multi-Service stakeholder engagement, develop and maintain TEMPs and test criteria, oversee corrective actions, and produce high-quality documentation ...
... FDA regulatory standards. They will manage multi-Service stakeholder engagement, develop and maintain TEMPs and test criteria, oversee corrective actions, and produce high-quality documentation ...
... and FDA regulatory standards. They will manage multi‑Service stakeholder engagement, develop and maintain TEMPs and test criteria, oversee corrective actions, and produce high‑quality ...
Quick apply
... and FDA regulatory standards. They will manage multi‑Service stakeholder engagement, develop and maintain TEMPs and test criteria, oversee corrective actions, and produce high‑quality ...
Temporary Fda Regulatory information
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$18.99 - $22.95
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$31.38 is the 25th percentile. Wages below this are outliers.
$30.86 - $34.81
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The median wage is $36.35 / hr.
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9% of jobs
$44.70 is the 75th percentile. Wages above this are outliers.
$42.72 - $46.68
10% of jobs
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6% of jobs
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5% of jobs
$54.59 - $58.54
5% of jobs
$58.54 - $62.50
3% of jobs
$18
$39
$62
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Posted 6 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