Clinical Regulatory Specialist: Trials Compliance & Submissions
$30 - $35 per hourCenExel
CenExel in Anaheim, California, is seeking a Regulatory Coordinator I responsible for regulatory research document preparation and organization. You will ensure compliance with FDA guidelines and maintain documentation for ongoing clinical trials. The ideal candidate has a high school diploma, at least 1 year of experience in clinical research, and strong organizational and communication skills. The job offers a Monday to Friday schedule with an hourly range of $30 to $35, based on experience. #J-18808-Ljbffr CenExel
$150k - $190k
...Principal Regulatory Affairs Specialist - Cardiac Ablation BIOTRONIK is one of the leading manufacturers... ...completed the First-in-Human clinical trial which validated the company's PFA... ...hands-on regulatory expert to lead our submission strategy and execution. The...SuggestedWork at officeImmediate startWork from homeRelocation package$30 - $35 per hour
...specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence... ...moderate oversight the Regulatory Coordinator I is... ...study start-up, including: Submission documents/approval, Protocol... ...Regulatory Coordinator or Specialist? ~ Demonstrated prioritization...SuggestedHourly payFull timeWork at officeMonday to FridayWeekend work$30 - $35 per hour
...Clinical Operations Specialist I Our client, a leading medical device and healthcare organization... ...'s the Job? Support clinical trial operations, including device lifecycle... ..., file archiving, and ensure compliance with regulatory requirements Track and coordinate...SuggestedHourly payFull time$94.5k - $141.8k
...Description: The Sr. Regulatory Affairs Specialist will be primarily... ...dental devices to ensure compliance with applicable regulations... ...international product registration submissions including 510ks, Conformit... ...deliverables for clinical studies. Mentors and guides...SuggestedFull timeContract workWork experience placementWork at office$61.05k - $77k
...Cordis is seeking a Clinical Trial Invoicing Assistant in Irvine, California, to support invoicing processes for clinical trials. The ideal candidate will have at least 1 year of experience in clinical studies under ICH and GCP guidelines and a Bachelor's degree. Key...Suggested- ...Pal Clinical Specialist The PAL Clinical Specialist supports the efficient... ...clinical judgment in submissions within UCI Health. The incumbent... ...accuracy and timeliness, ensuring compliance with clinical protocols, payer guidelines, and regulatory requirements. The position...Monday to FridayShift work
- ...Regulatory Affairs Representative Responsibilities: Represent... ...documentation for medical device submissions and effectively communicate... ...documentation (such as clinical evaluation reports, risk management... ...complex issues. Ensure compliance with product post marketing...
- ...Regulatory Affairs Specialist This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including...Work at office
- ...Who We Are UCI Health is the clinical enterprise of the University of California, Irvine, and the only academic health system... ...: Involves the review and evaluation of healthcare regulatory compliance controls and programs. Develops regulatory policies and...Full timeMonday to Friday
$60k - $65k
...SUMMARY: Supports tasks related to Regulatory and Compliance activities including tasks to ensure... ...necessary for Regulatory Agency submissions or in support of customer QARA needs... ...Quality Assurance/Regulatory Affairs Specialist MENTAL, PHYSICAL AND VISUAL...ApprenticeshipLocal area$70.3k - $103.82k
...Risk And Safety Compliance Coordinator Position Summary: Under general guidance of the General... ...Maintain OSHA Logs and annual OSHA Reporting and Submission of workplace injuries to DOL via ITA System Ensure required regulatory and compliance postings in all locations....Local area- ...Senior Regulatory Affairs Specialist Work mode: Hybrid Onsite Location(s): Marlborough... ...Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process... ...our global R&D, manufacturing, clinical, and quality teams. Work...Hourly payWork at officeLocal areaRelocationShift work3 days per week
$83.9k - $120k
...Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and device... ...on current regulations and guidelines. Evaluates compliance with applicable regulations, project policies, and...- ...Position : Regulatory Affairs Specialist Location : Irvine, CA Duration : 10 Months Total Hours... ...Devices Company Job Category : Clinical Level of Experience : Mid-Level... ...coordinating and implementing regulatory Submissions for products that require government...Contract workDay shift
- ...Pharma has an open position for a Senior Regulatory Affairs Specialist based in the Irvine, CA location.... ...: Planning: Oversee ANDA/NDA submission and approval process for regulatory.... ...Reviews documents for regulatory compliance necessary for the acceptability of quality...
$83.9k - $120k
...: Prepare and submit product registrations and submissions (510(k), PMA) to FDA and other regulatory bodies. Maintains company registrations and device... ...current regulations and guidelines. Evaluates compliance with applicable regulations, project policies, and...$80k - $100k
...The Regulatory Affairs Specialist is responsible for investigating and supporting... ...requirements and prepare regulatory submissions. Essential Functions... ...timely approval for clinical studies and product market... ...product files to support compliance with regulatory requirements...Full timeWork at officeLocal areaMonday to FridayAfternoon shift- ...Job Summary The Regulatory Affairs Specialist (FDA, DEA)will ensure BaRupOn's pharmacy, manufacturing... ...is responsible for preparing submissions, maintaining licenses, coordinating... ...Coordinate with Quality Assurance on SOP compliance, change controls, and deviation reports...
$170k - $200k
...this opportunity - Senior Principal Regulatory Affairs Specialist Description The Sr. Principal... ..., reviews and files regulatory submissions and documentation for the US and internationally... .... # Reviews device labeling for compliance with the applicable US and...- ...Responsibilities: Represent Regulatory Affairs on cross-functional... ...for medical device submissions and effectively communicate... ...technical documentation (such as clinical evaluation reports, risk management... ...complex issues. Ensure compliance with product post marketing...
- ...Roles & Responsibilities Support US and EU regulatory submissions, ensuring protection of proprietary information Track regulatory... ...registrations Product and process changes Labeling content and compliance Collaborate cross-functionally with internal teams...
- Cenexelresearch is seeking a Clinical Research - Regulatory Specialist in Anaheim, CA. This full-time, on-site role involves managing regulatory documents, supporting clinical trials, and liaising with investigators and IRBs. Successful candidates will have at least 1 year...Full time
$126.6k - $210.9k
...Senior Staff Regulatory Affairs Specialist Irvine, California As a Senior Staff Regulatory... ...development, quality, and clinical teams. This role offers meaningful... ...product classification, jurisdiction, submission pathways, and compliance activities to enable market...Temporary workLocal areaFlexible hours- ...divh2Clinical Imaging Specialist/h2pIntegrated Resources... ...:/pulliJob Title: Clinical Data Specialist/ Clinical... ...committee for US Pivotal trial./liliProduce sizing... ...timely manner./liliMeets submission deadlines for... ...liliSupports clinical study compliance requirements./liliCompletes...Overseas
- ...cost. Join us in our mission! SUMMARY The Payroll & Compliance Specialist plays a critical role in ensuring accurate, timely, and... ...for accuracy, completeness, and compliance prior to payroll submission Audit timecards, missed punches, premium pay, overtime,...Temporary workWork at officeWork from homeMonday to FridayFlexible hours
- ...CFI is seeking a registered securities principal to join our Compliance Department as a Regional Compliance Officer, supporting branch... ...application-way transactions, and various reports for compliance with regulatory standards and firm policies. Review and approve...RelocationNight shift
- ...Anaheim, CA, is seeking a full-time Registered Nurse (RN) for clinical data analysis and Core Measures oversight. The RN will oversee... ...validation, reporting, and conduct peer review activities to ensure compliance with quality standards. Candidates must have a Current...Full timeWork at office
$35 - $38 per hour
...reports, study reports, publications, or submissions) Ability to: Read, interpret, and... ...Description: ~ Supports early discovery / non-clinical work (no human clinical trials). Blend of: Scientific writing Regulatory-style documentation (light) High-...Contract workLocal areaRelocationShift work- A financial solutions company in the United States seeks licensed Life Insurance Agents to provide retirement accounts to interested clients exclusively through virtual consultations. This role offers full training, flexible working hours, high compensation, and the chance...Remote jobFlexible hours
- A proactive mortgage brokerage is seeking a Real Estate Agent to join their team as a Dually Licensed Agent. This role offers comprehensive training and multiple streams of income by serving clients in both real estate and mortgage financing. Candidates must have an active...Remote job
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