- Merck & Co. (South San Francisco, CA)
- …business goals and valuesSupports the site's recordkeeping and completion of regulatory submissions /notifications to maintain compliance with federal, state, and ... report submissions and training development/delivery.Assures completion of all regulatory submissions , notifications, etc. required to maintain compliance… 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
- Medtronic (Boston, MA)
- …partners with the international regulatory affairs group to support regulatory submissions worldwide. Sustaining regulatory responsibilities include ... Principal Regulatory Affairs Specialist - Surgical The...documentation is current and accurate. From developing and authoring regulatory submissions to providing critical input on… 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
- Teleflex (Wyomissing, PA)
- Sr. Regulatory Affairs Specialist **Date:** May 28, 2024 **Location:** Wyomissing, PA, US **Company:** Teleflex **Expected Travel** : Up to 10% **Requisition ... healthcare. For more information, please visit **teleflex.com** . **Global Operations -** Global Operations is a complex...a difference in patients' lives. **Position Summary** The Sr. Regulatory Affairs Specialist (SRA) will develop US,… more
- J&J Family of Companies (Warsaw, IN)
- … Regulatory Affairs Specialist will coordinate the day-to-day Regulatory Affairs operations as advised by the Associate Director related ... Regulatory Affairs Specialist II (DePuy Synthes)...and implementation plans, establishes accountability for the preparation of regulatory submissions . Prepare, draft and file … more
- Edwards Lifesciences (Irvine, CA)
- … agencies + Tracking timelines and documents milestone achievements for inclusion in regulatory submissions . + You may interact with regulatory agencies ... journey. **How you will make an impact:** As a Specialist , Regulatory Affairs for TMTT, you will...assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissions +… 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)
- …place to work for diversity, working mothers, female executives, and scientists This **Senior Regulatory Operations Specialist ** will work on-site out of our ... As an individual contributor, the function of a **Senior Regulatory Affairs Specialist ** is to provide support...Affairs Professionals Society.) + Medical devices and IVD international submissions experience + 3-5 years of regulatory … more
- Edwards Lifesciences (Irvine, CA)
- … approvals and clearances of assigned products. + Creating complex regulatory submissions (exercising judgment to protect proprietary information) for ... . **How you'll make an impact:** As a Senior Specialist , International Regulatory Affairs, you complete and maintain… more
- Abbott (Austin, TX)
- … understanding to support products and teams and will prepare US regulatory submissions and/or registration documents for international affiliates and government ... for diversity, working mothers, female executives, and scientists. **The Opportunity** This ** Regulatory Affairs Specialist II** position will work on-site out… 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
- 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
- BPL Plasma (Fort Lee, NJ)
- **Position** : Regulatory Affairs Specialist **Location** : Fort Lee, NJ **Duties and Responsibilities:** 1. Ensures Regulatory compliance within KEDPLASMA ... that corrective action is taken for consignee notification. Maintains regulatory files of all BPDR submissions . 1....1. Manages assists and/or performs various projects within the operations , regulatory and quality groups as requested.… 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
- Edwards Lifesciences (Irvine, CA)
- …to regulatory agencies + Tracking timelines and documents for inclusion in regulatory submissions ; may interact with regulatory agencies as part of ... **How you will make an impact:** As a Senior Specialist , Regulatory Affairs, you work with other...submissions + Basic knowledge and understanding of global regulatory requirements for new products or product changes +… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …community-based research, and laboratory-based translational human immunology. The Clinical Trials Regulatory Specialist I is an entry-level position supporting ... a relatively small trial portfolio. KEY RESPONSIBILITIES: + Assists regulatory team ( Regulatory Specialist II...IRB and sponsoring entities. + Supports the Assistant Director, Operations Manager, and Regulatory Coordinators II/III in… 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
- 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
