Position Details: * Full-time position * Regular weekly hours (0900-1600) * No calls, nights ... Possess a Regulatory Affairs Certification (RAC). Summary: CICONIX is seeking a Senior Regulatory ...
Position Details: * Full-time position * Regular weekly hours (0900-1600) * No calls, nights ... Possess a Regulatory Affairs Certification (RAC). Summary: CICONIX is seeking a Senior Regulatory ...
Regulatory Affairs Certification (RAC). Knowledge and Skills: * Organization & Planning: Organizes personal and organizational projects and tasks, for assigned projects, enlisting resources to ...
Regulatory Affairs Certification (RAC). Knowledge and Skills: * Organization & Planning: Organizes personal and organizational projects and tasks, for assigned projects, enlisting resources to ...
Advanced degree and/or Regulatory Affairs Certification (RAC) preferred. * Ability to clearly communicate and write reports and business correspondence in English. Ability to effectively present ...
New
Advanced degree and/or Regulatory Affairs Certification (RAC) preferred. * Ability to clearly communicate and write reports and business correspondence in English. Ability to effectively present ...
New
Advanced degree (e.g., Master's, PhD, or Regulatory Affairs Certification (RAC)) is a plus ... Direct Clients This is a full time position
Advanced degree (e.g., Master's, PhD, or Regulatory Affairs Certification (RAC)) is a plus ... Direct Clients This is a full time position
RAPS Regulatory Affairs Certification (RAC) is a plus. Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you ...
RAPS Regulatory Affairs Certification (RAC) is a plus. Additional Information Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you ...
Regulatory Affairs Strategist, Globalization (eIPRRA)
Franklin Lakes, NJ · On-site
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Regulatory Affairs Certification (RAC). Knowledge and Skills: * Organization & Planning: Organizes personal and organizational projects and tasks, for assigned projects, enlisting resources to ...
Regulatory Affairs Strategist, Globalization (eIPRRA)
Franklin Lakes, NJ · On-site
$152K - $201K/yr
Regulatory Affairs Certification (RAC). Knowledge and Skills: * Organization & Planning: Organizes personal and organizational projects and tasks, for assigned projects, enlisting resources to ...
Preferred Skills and Experience • RAPS Regulatory Affairs Certification (RAC) is a plus. Additional Information Due to the nature of our business and the role, please note that Intuitive and/or ...
Preferred Skills and Experience • RAPS Regulatory Affairs Certification (RAC) is a plus. Additional Information Due to the nature of our business and the role, please note that Intuitive and/or ...
CMS Chemical Regulatory Manager
$105K - $120K/yr
Regulatory Affairs Certification (RAC) * Certified Chemical Professional (CCP) Location: Foothill Ranch, CA (Hybrid)Pay Range: $105k/yr - $120k/yr
CMS Chemical Regulatory Manager
$105K - $120K/yr
Regulatory Affairs Certification (RAC) * Certified Chemical Professional (CCP) Location: Foothill Ranch, CA (Hybrid)Pay Range: $105k/yr - $120k/yr
Senior Regulatory Affairs Specialist (Columbia, MD)
Columbia, MD · Hybrid
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Regulatory Affairs Certification (RAC Devices) preferred. * Minimum of 5 years of handson experience in Regulatory Affairs. * Proven experience supporting and/or leading FDA 510(k) submissions and ...
Senior Regulatory Affairs Specialist (Columbia, MD)
Columbia, MD · Hybrid
$101K - $152K/yr
Regulatory Affairs Certification (RAC Devices) preferred. * Minimum of 5 years of handson experience in Regulatory Affairs. * Proven experience supporting and/or leading FDA 510(k) submissions and ...
Senior Regulatory Affairs Specialist (Columbia, MD)
Columbia, MD · On-site
$101K - $152K/yr
Regulatory Affairs Certification (RAC Devices) preferred. * Minimum of 5 years of hands-on experience in Regulatory Affairs. * Proven experience supporting and/or leading FDA 510(k) submissions and ...
Senior Regulatory Affairs Specialist (Columbia, MD)
Columbia, MD · On-site
$101K - $152K/yr
Regulatory Affairs Certification (RAC Devices) preferred. * Minimum of 5 years of hands-on experience in Regulatory Affairs. * Proven experience supporting and/or leading FDA 510(k) submissions and ...
Regulatory Affairs Certification (RAC). Knowledge and Skills: * Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and ...
New
Regulatory Affairs Certification (RAC). Knowledge and Skills: * Organization & Planning: Independently organizes personal and organizational projects and tasks, setting measurable objectives and ...
New
Regulatory Affairs Certification (RAC). Knowledge and Skills: * Organization & Planning: Organizes personal and organizational projects and tasks, for assigned projects, enlisting resources to ...
Regulatory Affairs Certification (RAC). Knowledge and Skills: * Organization & Planning: Organizes personal and organizational projects and tasks, for assigned projects, enlisting resources to ...
CMS Chemical Regulatory Manager
Foothill Ranch, CA · On-site
$105K - $120K/yr
Regulatory Affairs Certification (RAC) * Certified Chemical Professional (CCP) Location: Foothill Ranch, CA (Hybrid) Pay Range: $105k/yr - $120k/yr Equal Opportunity Employer This employer is ...
CMS Chemical Regulatory Manager
Foothill Ranch, CA · On-site
$105K - $120K/yr
Regulatory Affairs Certification (RAC) * Certified Chemical Professional (CCP) Location: Foothill Ranch, CA (Hybrid) Pay Range: $105k/yr - $120k/yr Equal Opportunity Employer This employer is ...
Regulatory Affairs Certification (RAC). Knowledge and Skills: * Organization & Planning: Organizes personal and organizational projects and tasks, for assigned projects, enlisting resources to ...
Regulatory Affairs Certification (RAC). Knowledge and Skills: * Organization & Planning: Organizes personal and organizational projects and tasks, for assigned projects, enlisting resources to ...
Regulatory Affairs Certification (RAC) or equivalent professional certification. * Previous people management experience. * Experience with color additive petitions, GRAS notifications, novel ...
New
Quick apply
Regulatory Affairs Certification (RAC) or equivalent professional certification. * Previous people management experience. * Experience with color additive petitions, GRAS notifications, novel ...
New
Regulatory Affairs Certification (RAC) or equivalent professional certification. * Previous people management experience. * Experience with color additive petitions, GRAS notifications, novel ...
Regulatory Affairs Certification (RAC) or equivalent professional certification. * Previous people management experience. * Experience with color additive petitions, GRAS notifications, novel ...
Regulatory Affairs Manager
Mount Pleasant, WI · On-site
Regulatory Affairs Certification (RAC) or equivalent professional certification. * Previous people management experience. * Experience with color additive petitions, GRAS notifications, novel ...
Regulatory Affairs Manager
Mount Pleasant, WI · On-site
Regulatory Affairs Certification (RAC) or equivalent professional certification. * Previous people management experience. * Experience with color additive petitions, GRAS notifications, novel ...
Regulatory Affairs Certification (RAC) At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast ...
Regulatory Affairs Certification (RAC) At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast ...
RAC - Regulatory Affairs Certifications (RAPS) or * CCRC - Certified Clinical Research Coordinator (ACRP) or * CCRP - Certified Clinical Research Professional (SOCRA) SKILLS AND ABILITIES
RAC - Regulatory Affairs Certifications (RAPS) or * CCRC - Certified Clinical Research Coordinator (ACRP) or * CCRP - Certified Clinical Research Professional (SOCRA) SKILLS AND ABILITIES
A Day in the Life The Senior Regulatory Affairs Specialist will play a key role in supporting ... RAC certification or progress toward RAC certification * Experience supporting Class II and Class ...
A Day in the Life The Senior Regulatory Affairs Specialist will play a key role in supporting ... RAC certification or progress toward RAC certification * Experience supporting Class II and Class ...
Full Time Rac Regulatory Affairs Certification information
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$19.04 is the 25th percentile. Wages below this are outliers.
$15.63 - $27.45
86% of jobs
$27.45 - $39.27
5% of jobs
$39.27 - $51.09
0% of jobs
$51.09 - $62.92
5% of jobs
$62.92 - $74.74
1% of jobs
$74.74 - $86.56
2% of jobs
$86.56 - $98.38
0% of jobs
$98.38 - $110.21
0% of jobs
$110.21 - $122.03
0% of jobs
$122.03 - $133.85
0% of jobs
$133.85 - $145.67
0% of jobs
$15
$34
$145
How much do full time rac regulatory affairs certification jobs pay per hour?
What is the difference between Full Time Rac Regulatory Affairs Certification vs Full Time Regulatory Affairs Specialist?
| Aspect | Full Time Rac Regulatory Affairs Certification | Full Time Regulatory Affairs Specialist |
|---|---|---|
| Credentials | Certification in RAC | Typically requires a degree in life sciences or related field; certification preferred |
| Work Environment | Primarily exam-focused, often involves ongoing education | Office-based, involves preparing regulatory submissions and liaising with authorities |
| Industry Usage | Used to demonstrate expertise and advance career | Job role involving regulatory compliance and submissions |
In summary, the Full Time Rac Regulatory Affairs Certification is a credential that validates expertise in regulatory affairs, often enhancing career prospects. The Full Time Regulatory Affairs Specialist is a job role that applies this knowledge in daily tasks. While certification can be a career booster, the specialist role involves hands-on regulatory work.
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Full-time
Medical, Retirement, PTO
Re-posted 16 days ago
Job description
- Full-time position
- Regular weekly hours (0900-1600)
- No calls, nights, weekends, or holidays!
- Full benefit program, including: health, PTO, & 401k + contribution
- Possess a Regulatory Affairs Certification (RAC).
- Ensure compliance with FDA Sponsor responsibilities, serve as a subject matter expert for regulatory strategy including identifying and mitigating risk, and providing support to integrated project teams and working groups for submissions to and communications with the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health submissions. Regulatory Affairs support includes but is not limited to the following:
- Provide subject matter expertise on all regulatory matters related to assigned regulatory projects; ensure ORA leadership and the sponsor’s representative are kept current on the progress of the program through periodic reports.
- Provide regulatory support to an integrated product team or working group, which includes working with the team members, advising the team on any FDA-related activities and issues, and attending meetings, updating ORA leadership and the sponsor’s representative through routine reports.
- Lead the development of a written regulatory strategy and provide to the Government The strategy shall describe the regulatory pathway for FDA regulatory approval/licensure/clearance, any possible post-marketing commitments, and shall also describe the target product profile or equivalent that can be used throughout the development process that will describe how a product will be utilized by the end user and provide to the Government.
- Create or provide input to and maintain Target Product Profiles and provide to the Government. The target product profiles shall contain the indication and usage, dosage and administration, dose forms and strengths, contraindications, warning and precautions, safety adverse reactions and drug interactions, use in specific populations, drug abuse and dependence/overdose, description of drug, clinical/pharmaceutical, pre-clinical toxicology, clinical studies, references, storage and handling, patient counseling, risk evaluation mitigation strategy, and supporting documentation and/or templates as appropriate.
- Identify and mitigate regulatory risk through a project Risk Register.
- Serve as the primary contact with the FDA for assigned products; review, analyze, and respond to FDA communications and meetings by the regulatory deadline and maintain meeting minutes in EDMS.
- Coordinate, prepare, write, review, obtain, maintain, and archive the required documents for regulatory submissions in EDMS.
- Participate and represent as regulatory subject matter expert in on-site visits at the industry partner manufacturing facility as requested.
- Provide regulatory assistance for Quality Management System assessments done at the manufacturing facility performed by ORA or external consultants.
- Assist in writing and/or reviewing abstracts, papers, and publications, which shall be written in collaboration with the study team members and submitted to all appropriate approval authorities.
- Enter information in ClinicalTrials.gov for clinical studies prior to study initiation. Provide quality assurance for the data and information entered, and ensure compliance with the current regulatory, DHA, and ORA requirements to include upload of required documents, record verification at least once every 6 months, and updates within 30 days for changes to recruitment status, sponsor IRB, approval etc. Enter clinical study results NLT 12 months after the study’s primary completion date.
- Review and provide written critical regulatory feedback on acquisition milestone decision briefings, progress reviews, and other acquisition documents.
- Train, and develop regulatory staff, managing workloads and ensuring alignment with project and program objectives.
- Lead and/or actively participate in working groups for ORA process improvement, continued learning, regulatory intelligence, and quality review.
- Write, review, and/or revise SOPs.
- Provide subject matter expertise on all FDA regulatory matters related to assigned regulatory projects; monitor emerging regulations (United States and global), trends, and agency expectations to assess impact and advise ORA leadership and the sponsor’s representative.
- Education:
- TBD
- Licensure & Certifications (Current & Unrestricted):
- Possess a Regulatory Affairs Certification (RAC).
- Experience:
- TBD
- Security & Background Check:
- U.S. Citizenship and a successful background investigation are required.
- Ability to obtain and maintain a government security clearance.
- Additional Requirements:
- Willingness to comply with the government vaccination requirements.
About CICONIX
Sourced by ZipRecruiter
Industry
Business management consulting
Company size
11 - 50 Employees
Headquarters location
Annapolis, MD, US
Year founded
2012