- LSI Solutions (Victor, NY)
- …state-of-the-art devices. After all, our customer is ultimately the patient. JOB TITLE: Regulatory Specialist (Labeling) - Days 8:00AM to 5:00PM SALARY RANGE: ... at LSI Solutions in Victor, NY JOB SUMMARY: The Regulatory Specialist applies her/his experience, knowledge, organization...to Domestic Regulatory Projects will 1) prepare regulatory submissions , including FDA Q- Submissions ,… more
- Teleflex (Maple Grove, MN)
- …a difference in patients' lives. **Position Summary** The Regulatory Affairs Specialist will develop strategies, submissions , and regulatory reviews of ... Regulatory Affairs Specialist **Date:** Sep 14,...product development to assure collection of appropriate data for regulatory submissions and regulatory compliance.… more
- Kelly Services (Redondo Beach, CA)
- …Operations to Ensure Clinical Study Results and Reports are Suitable for Regulatory Submissions + Responsible for Adverse Event (Vigilance, MDR) Reporting and ... **Title** : Regulatory Affairs Specialist (Senior Level) **Pay**...Regulatory Representative to Marketing, Clinical, Research Teams, and Regulatory Agencies + Ensure Regulatory Submissions… more
- Randstad US (Fort Worth, TX)
- …Submissions + Good Communication Skills skills: GCP (Good Clinical Practice), Regulatory Affairs Operations , Submissions Equal Opportunity Employer: Race, ... regulatory affairs specialist i. + fort...follow-up information as requested. + Coordinate, prepare, or review regulatory submissions for domestic or international projects.… more
- Randstad US (Los Angeles, CA)
- regulatory specialist . + los angeles , california (remote) + posted 5 days ago **job details** summary + $40 per hour + contract + bachelor degree + category ... + Utilize scientific training to guide experimentation scope and data selection for regulatory submissions . + Interact with regulatory authorities on… more
- Medtronic (Minneapolis, MN)
- … affairs specialist and in country specialists as needed, to support regulatory submissions worldwide for Class I, II, and Class III medical devices. ... II and Class III medical devices. The Sr Principal Regulatory Affairs Specialist is responsible for activities...Activities will include careful and clear documentation of regulatory decisions, authoring well written submissions to… more
- Medtronic (Irvine, CA)
- …partners with the international regulatory affairs group to support regulatory submissions . Sustaining regulatory responsibilities include reviewing ... a global medical technology and solutions leader. The **Senior Regulatory Affairs Specialist ** will be vital in...standards. + Create or revise departmental procedures to improve operations or to reflect changing regulatory requirements.… more
- Teleflex (Maple Grove, MN)
- Sr. Regulatory Affairs Specialist **Date:** Sep 23, 2024 **Location:** Maple Grove, MN, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... will be at moderate to complex level, and relate to regulatory documents, submissions , investigations, product development planning and regulatory… more
- Integra LifeSciences (Princeton, NJ)
- … strategies, and create and revise technical documentation for existing and new regulatory submissions . + Prepare regulatory strategies under supervision. ... response to questions under supervision. + Ensure timeliness of regulatory submissions according to business needs. +...and international regulatory teams. + Coordinate with Regulatory Operations for updates to the Unique… more
- Abbott (Sylmar, CA)
- …compliance with applicable regulations. + Reviews protocols and reports to support regulatory submissions . + Supports all business segment initiatives as ... employees, customers, contractors, and vendors. + Provides mentoring and leadership to Regulatory Specialist I and II team members **Required Qualifications** +… more
- West Pharmaceutical Services (Exton, PA)
- …software and regulatory tools. + Proven track record of successful regulatory submissions and interactions with regulatory authorities. + Experience ... Sr. Specialist , Regulatory Project Mgmt Requisition ID:...regulatory team through all project phases to support submissions including Premarket Notifications, Technical Documentations under EU MDR… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Provides guidance to investigators and study teams regarding completion of IRB regulatory submissions (eg, new project applications, activation, amendments, and ... The Regulatory Affairs Specialist (RAS) positions provides...regulations apply to their research, consultation and education regarding regulatory requirements, review of FDA submissions for… more
- Envista Holdings Corporation (Brea, CA)
- …and standard operating procedures (SOPs) and technical documentation that link to regulatory operations . Clear documentation is essential for compliance. + ... **Job Description:** **JOB SUMMARY** : The ** Regulatory Affairs Specialist (RA Specialist...compliance with regulations and guidance. + Prepare and maintain regulatory submissions , product registrations, certifications, and facility… more
- Abbott (Santa Clara, CA)
- …to support of product and teams as well as prepare US/CE regulatory submissions and/or registration documents for international affiliates and government ... heart disease. **The Opportunity** We are recruiting for a ** Regulatory Affairs Specialist II** to join our...operations day-to-day activities for change control and provide regulatory direction on team activities. The individual will apply… more
- Integra LifeSciences (Harrisburg, PA)
- … strategies, and create and revise technical documentation for existing and new regulatory submissions . + Prepares regulatory strategies with minimal ... to questions with minimal supervision. + Ensure timeliness of regulatory submissions according to business needs. This...and international regulatory teams. + Coordinates with Regulatory Operations for updates to the Unique… more
- Stanford University (Stanford, CA)
- Clinical Trials Regulatory Specialist **School of Medicine, Stanford, California, United States** **New** Research Post Date 2 days ago Requisition # 104747 ... care. The PACCM is seeking a full-time Clinical Trials Regulatory Specialist (CTRS) to join our expanding...compile research protocol documents and all materials required for regulatory submissions in compliance with university and… more
- Abbott (Irving, TX)
- …**Irving, TX** or **Abbott Park, IL** currently has an opportunity for a **Senior Regulatory Affairs Specialist .** **What You'll Work On** + Participate as the ... Our 114,000 colleagues serve people in more than 160 countries. **_Senior Regulatory Affairs Specialist_** **Working at Abbott** At Abbott, you can do work… more
- Weill Cornell Medical College (New York, NY)
- Title: Regulatory & Protocol Development Specialist Location: Midtown Org Unit: Regulatory Work Days: Monday-Friday Weekly Hours: 35.00 Exemption Status: ... + Serves as a functional area subject matter expert for protocol writing, FDA submissions , and regulatory reporting. + Performs other related duties as assigned… more
- Abbott (Sylmar, CA)
- …requests for product release. + Reviews protocols and reports to support regulatory submissions . + Supports all business segment initiatives as identified ... arrhythmias, or irregular heartbeats. **The Opportunity** We are presently hiring for a ** Regulatory Affairs Specialist II** to work on-site at our Cardiac… more
- Abbott (St. Paul, MN)
- …treatment of structural heart disease. **The Opportunity** We are recruiting for a **Senior Regulatory Affairs Specialist ** to join our team on-site in St. Paul, ... MN.This new team member will provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may… more
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