- DivIHN Integration Inc (Lake Forest, IL)
- … day to day activities for change control. Provides consultation/advice to regulatory specialist for change control and product development. Provides ... Talent Specialists Rashi at ### Meghna at ### Title: Regulatory Affairs Specialist II - 5 Openings...understanding to support of products and teams. Prepares US regulatory submissions and/or registration documents for international… more
- DivIHN Integration Inc (Scarborough, ME)
- …contact one of our Talent Specialist Rashi | 630 8471027 Title: Regulatory Specialist II Location: Scarborough, ME Duration: 7 months Start Time (AM/PM) ... day to day activities for change control. Provides consultation/advice to regulatory specialist for change control and product development. Provides … more
- George Washington University (Washington, DC)
- …staff alignment with requisite expertise; ensuring appropriate staff coverage for regulatory operations ; Develops and maintains and enforces safety standards, ... administrative teams are appropriately trained to provide comments to the applicable regulatory committees for consideration with submissions to assure that the… more
- Creative Financial Staffing (Stamford, CT)
- …accuracy and adherence to deadlines. Execute payroll adjustments, oversee employee portal submissions , and act as a proficient backup for the Payroll Specialist ... maintain data integrity across multiple states, ensuring consistency and compliance with regulatory requirements. Contribute to the upkeep of the ERP system and… more
- Novo Nordisk (Princeton, NJ)
- …living. Are you ready to make a difference? The Position The Specialist , Regulatory Operations - Submissions supports the development of submission plans ... created for regulatory submissions . This individual will be responsible for supporting the preparation, delivery, archiving and tracking of Promotional … more
- Abbott (Alameda, CA)
- …to work for diversity, working mothers, female executives, and scientists This **Senior Regulatory Operations Specialist ** will work out of our Alameda, ... As an individual contributor, the function of a **Senior Regulatory Affairs Specialist ** is to provide support...the input of cumulative product changes to current product submissions . + Contribute to the development and functioning of… more
- Cook Medical (Pittsburgh, PA)
- …Administration and other Regulatory agencies, as well as providing Regulatory Operations support. Responsibilities * Preparation, coordination / compilation ... driven by integrity, we invite you to apply. The Regulatory Publishing Specialist II at Cook MyoSite,...of Regulatory submissions , publications, and filings to US...of Regulatory submissions , publications, and filings to… more
- Teleflex (Maple Grove, MN)
- …a difference in patients' lives. **Position Summary** The Regulatory Affairs Specialist will develop strategies and submissions for projects and issues ... Sr. Regulatory Affairs Specialist **Date:** May 12,...related to regulatory documents, global submissions , investigations, product development planning, and regulatory … more
- Integra LifeSciences (GA)
- … regulatory strategies, and revise technical documentation for existing and new regulatory submissions . + Lead in the development of US and International ... and making headway to help improve outcomes. The Sr. Regulatory Affairs Specialist is a seasoned senior...(510k, PMA, BLA) with minimal supervision. Ensure timeliness of regulatory submissions according to business needs. This… more
- Abbott (Santa Clara, CA)
- …clinical documentation for submission filing. + Compile, prepare, review and submit regulatory submissions to authorities. + Monitor impact of changing ... catheters and software, vessel closure devices and peripheral stents. This **Senior Regulatory Affairs Specialist ** position is an on-site opportunity working… more
- Abbott (Alameda, CA)
- …regulatory understanding to support of product and teams. Prepares US regulatory submissions and/or registration documents for international affiliates and ... work for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Specialist II - APAC** will work out of our… more
- Edwards Lifesciences (Irvine, CA)
- … approvals and clearances of assigned products. + Creating complex regulatory submissions (exercising judgment to protect proprietary information) for ... . **How you will make an impact:** As a Senior Specialist , International Regulatory Affairs, you complete and maintain … more
- Stanford University (Stanford, CA)
- Clinical Trials Regulatory Specialist 2 **School of Medicine, Stanford, California, United States** Research Post Date Feb 16, 2024 Requisition # 100464 ... improve human health. SCCR seeks a mission-driven Clinical Trials Regulatory Specialist 2. You will work with...apply! This position is remote. **Duties include:** + Prepare regulatory submissions (such as IRB and IND/IDE)… more
- Abbott (Alameda, CA)
- …glucose levels with our new sensing technology. **The Opportunity** This **Senior International Regulatory Operations Specialist ** will work on-site at our ... levels with our new sensing technology. As an individual contributor, the Senior Specialist will provide support for the regulatory department to ensure… more
- Kelly Services (Round Lake, IL)
- …**Compensation** : based on experience **Responsibilities:** + Managing the preparation of regulatory submissions for IND, ANDA, NDA, 510K, AdProm, and other ... Kelly Science & Clinical is seeking a ** Regulatory Affairs Ops Specialist near Round...different milestones. + Working cross functionally with project management, operations , IT and other functions. + Coordinate submission scheduling… more
- Abbott (Alameda, CA)
- … submission strategies. + Assist in the preparation and review of regulatory submissions to authorities. + Assist compliance with product post-marketing ... with our new sensing technology. **The Opportunity** We are presently hiring for a ** Regulatory Affairs Specialist ,** as part of the Regulatory Affairs Asia… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …of our academic community. **Description** JOB DESCRIPTION: + The Clinical Trials Regulatory Specialist I is an entry-level position supporting regulatory ... relatively small trial portfolio. + Duties include: + Assists regulatory team ( Regulatory Specialist II...IRB and sponsoring entities. + Supports the Assistant Director, Operations Manager, and Regulatory Coordinators II/III in… more
- Abbott (Plymouth, MN)
- … agencies if so directed. + Reviews protocols and reports to support regulatory submissions . + Support all Company initiatives as identified by management ... on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Regulatory Affairs Specialist II** to join our team on-site in Plymouth,… more
- Medtronic (Minneapolis, MN)
- …Quality Management Systems. * Direct coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits, and ... LIVES** The strategic intent of the newly designed Global Operations and Supply Chain (GO&SC) Operating Unit is to...to significantly optimize our supply base. As a Senior Regulatory Affair Specialist supporting STOP, you will… more
- Edwards Lifesciences (Irvine, CA)
- … submissions . Track timelines and documents milestone achievements for inclusion in regulatory submissions . May interact with regulatory agencies as part ... difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and… more
