Clinical Trials Regulatory Specialist — IRB & Submissions
Stanfordlivetickets
The Department of Anesthesiology, Perioperative and Pain Medicine at Stanford Medicine is seeking a Clinical Trials Regulatory Specialist 1 to provide centralized regulatory support for a diverse portfolio of clinical research. The role emphasizes HRPP/IRB coordination, regulatory submissions, and ongoing compliance across drugs, devices, and AI-enabled studies. You will train investigators and staff, develop SOPs, and monitor submissions while guiding teams through IRB inquiries and continuing #J-18808-Ljbffr Stanfordlivetickets
- ...Medicine at Stanford Medicine is seeking a Clinical Trials Regulatory Specialist 1 to provide centralized regulatory... ...Study Start-Up and Regulatory Submissions. This position supports new clinical... ...through Institutional Review Board (IRB) processes, from initial submission...SuggestedLocal areaWorldwide
- ...Anesthesiology, Perioperative and Pain Medicine seeks a Clinical Trials Regulatory Specialist 1 to provide centralized regulatory support across a diverse... ...research portfolio. The role guides teams through HRPP/IRB processes and ensures compliance from concept to activation...Suggested
- Summit Therapeutics Inc. is seeking an Associate of Regulatory Affairs to support day-to-day regulatory activities for assigned projects, including CTA/IND submissions and health-authority interactions. The role involves coordinating submissions, maintaining timelines,...Suggested
$90k - $180k
Abbott Laboratories is seeking a Senior Regulatory Affairs Specialist at their Santa Clara, CA location. This role involves supporting the regulatory... ...regulatory input for product lifecycles and handling submissions to regulatory authorities. The ideal candidate should...Suggested$145k - $167k
...transformational, accessible, clinically relevant diagnostic imaging.... ...The RoleJob Title: Senior Regulatory Affairs SpecialistLocation:Palo... ...Senior Regulatory Affairs Specialist advises regulatory strategy... ...responsible for ensuring regulatory submissions and registrations are...SuggestedWork experience placementWork at officeWorldwideWork visaNight shiftWeekend work3 days per week- ...Client, an American Biotechnology company, is looking for a Regulatory Affairs Specialist 4 for their Sunnyvale, CA/Hybrid location.... ...international counterparts to support global regulatory submissions, approvals, and implementation rollouts. Requirements...
$55 - $60 per hour
...Job Title: Sr. Regulatory Affairs Specialist Location: Sunnyvale, CA, United States Type: Contract Compensation: $55.0... ...design/process changes. Prepare and maintain regulatory submissions, including U.S. FDA 510(k) premarket notifications,...Contract workTemporary workLocal area$97k - $114k
...change lives through Summit’s clinical studies in the field of... ...not presently approved by any regulatory authority other than China’s... ...preparation and compilation of submissions for regulatory agencies, clinical... ..., including clinical trial application (CTA) and IND submissions...Contract workFor contractorsFor subcontractor$97k - $114k
...Cancer (NSCLC) HARMONi: Phase 3 clinical study which was intended to... ...presently approved by any regulatory authority other than China’s... ...preparation and compilation of submissions for regulatory agencies, clinical... ..., including clinical trial application (CTA) and IND submissions...$55 - $60 per hour
...Job Description Job Description Job Title: Regulatory Affairs Specialist IV Location: Sunnyvale, California Type: 6 month contract Compensation... ...Hours: 40.0 Overview Lead regulatory strategy and submissions for medical devices, supporting product development,...Contract workLocal area$90k - $180k
...SCJob Type: Full timeCategory: Regulatory AffairsIndustry:... ...a Senior Regulatory Affairs Specialist is to provide support for the... .... Determine and communicate submission and approval requirements. Participate... ...of quality, preclinical and clinical documentation for submission...Work experience placementWorldwide$171k - $231.4k
...Operational Compliance Team (MD-OCC), the Sr. Regulatory Affairs Specialist will be working to build best in... ...practical hands-on knowledge of FDA submissions and reporting requirements across... ...chain experts, regulatory experts, clinical affairs, and internal auditors. Our...For contractorsLocal areaFlexible hours- ...of Position This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global... .... • Mentor and coach regulatory affairs specialists. • Track and report metrics on regulatory timelines...Local areaWorldwideFlexible hours
$90k - $180k
...devices and peripheral stents.This Senior Regulatory Affairs Specialist position is an on-site opportunity... ...approval.Determine and communicate submission and approval requirements.... ...acceptability of quality, preclinical and clinical documentation for submission filing....WorldwideShift work$81.5k - $141.3k
...Opportunity Abbott is seeking a passionate, experienced Regulatory Affairs Specialist to join our Vascular Division team on-site in Santa Clara... ...product lifecycle. Proven successful track record of preparing submissions and documentation in compliance with relevant medical...For contractorsShift work$100k - $200k
...motivated and experienced Principal Regulatory Affairs Specialist to join our Vascular Division team on... ...regulatory assessments, and global submissions. This individual will serve as a key... ...with Regulatory Operations, Quality, Clinical, R&D, Manufacturing, Supply Chain,...For contractorsShift work- ## Principal Regulatory Affairs SpecialistApplylocations: California - Headquarterstime type... ...You:**The Principal Regulatory Affairs Specialist provides regulatory leadership for... ...coordination and preparation of regulatory submissions and for the development/revision of...Work at office
- ...company that's transforming cardiac care with innovative solutions. The client seeks a Principal Regulatory Affairs Specialist to lead complex regulatory strategies and submissions for Class III implantable devices and software-driven technologies. Responsibilities Author...
- ...life. Position Overview The Principal Regulatory Affairs Specialist drives the full spectrum of... ...across the Pulmonx portfolio; drive submission type selection, timeline planning, and... ...mitigation decisions aligned to business and clinical objectives. Manage the full...
- ...Sr. Regulatory Affairs Specialist We are searching for an experienced regulatory professional to work within the Companion Diagnostics (CDx)... ...Pharmaceutical, with a history of successful regulatory submissions, registrations, 510(k)'s and PMA approvals in US and Asia...
$120k - $150k
...Certificates, Waivers & COAs Partner closely with engineering and flight test teams to ensure compliance alignment early in design Regulatory Engagement Serve as primary Pivotal representative to: Aeronautical Authorities including FAA (and offices including AIR,...Work at officeLocal area- ...The Senior Regulatory Affairs Specialist leads regulatory operations activities with a focus on global tender support, regulatory documentation... ...Affairs, Regulatory Operations, or international regulatory submissions. Experience managing complex cross-functional projects...
- Title : Regulatory Specialist Sr Location : Santa Clara, California, 100% Onsite Duration : 12 months Summary The ideal candidate operates with... ..., evidence of conformance, etc) Executes preparation and submission of Certificates to Foreign Governments (CFGs), CFG-NE, COEs...Temporary workFlexible hours
$92k - $148.35k
...their merit. Job Function Regulatory Affairs Group Job Sub Function... ...a Senior Regulatory Affairs Specialist to support our... ...exceptional engineering and clinical teams, as well as supporting... ...development stages and generating submission ready documentation and authoring...Local areaImmediate startRemote work- ...robotic products designed to improve clinical outcomes of patients through... ...challenges worldwide. Position Senior Regulatory Affairs Specialist (Contract Basis) - Hybrid (3 days on... ...and lead regulatory documentation and submissions, including FDA 510(k) pre‑market notifications...Contract workFor contractorsRemote workWorldwide2 days per week
- Abbott is hiring a Regulatory Affairs Specialist for their Vascular Division in Santa Clara, CA. This role focuses on supporting EU and US regulatory... ...include developing regulatory strategies and preparing submissions, contributing significantly to product compliance and...
$92.7k - $152.9k
...Description Summary Sr. International Regulatory Affairs Specialist to join our Regulatory Affairs team.... ...preparing and managing regulatory submissions to support global commercialization... ...regulatory impact. Review analytical and clinical protocols to ensure appropriate data...Work experience placementLocal area- ...supporting teams, make sure the company's regulatory affairs activities are conducted in... ...Coordinate and assist in efforts of regulatory/clinical strategy development and timeline... ...the deliverables prepared for NMPA submission are compliant. Coordinate and prioritize...For contractorsLocal areaWorldwideFlexible hours
- ...of Position: This role provides expert support for regulatory project management, strategic submissions, and cross-functional compliance activities in global... .... Mentor and coach regulatory affairs specialists. Track and report metrics on regulatory timelines...Local areaWorldwideFlexible hours
- Summit Therapeutics Inc. is seeking an Associate of Regulatory Affairs to support day-to-day regulatory activities for assigned projects, including submissions to regulatory agencies and maintenance of submission timelines. The role involves coordinating with cross-functional...
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