- Cardinal Health (Sacramento, CA)
- **What Regulatory Submissions Operations contributes to Cardinal Health** Regulatory provides regulatory affairs and product development consulting ... subject matter expertise to provide services in technical writing and regulatory submissions as well as clinical research and manufacturing process consulting. … more
- Actalent (Agoura Hills, CA)
- Job Title: Regulatory Specialist Job Description As a Senior Regulatory Specialist , you will develop and implement medical device regulatory ... worldwide regulatory bodies. This role involves developing and authoring regulatory submissions , providing critical input on cross-functional project teams,… more
- Abbott (Santa Clara, CA)
- …catheters, imaging catheters and software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite ... Division. As an individual contributor, the function of a Senior Regulatory Affairs Specialist is...for submission filing. + Compile, prepare, review and submit regulatory submissions to authorities. + Monitor impact… more
- Abbott (Alameda, CA)
- …best place to work for diversity, working mothers, female executives, and scientists This ** Senior Regulatory Affairs Specialist ** will work on-site out of ... with our new sensing technology. **The Opportunity** As an individual contributor, the Senior Regulatory Affairs Specialist will support product development… more
- Edwards Lifesciences (Irvine, CA)
- … submissions . Track timelines and documents milestone achievements for inclusion in regulatory submissions . May interact with regulatory agencies as part ... more about BD at bd.com **How you'll make an impact:** + Represent the regulatory function on manufacturing and product development teams to provide input on … 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
- Edwards Lifesciences (Irvine, CA)
- …regulatory agencies. Track timelines and documents milestone achievements for inclusion in regulatory submissions . + May interact with regulatory agencies ... difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international… more
- Caldera Medical (Westlake Village, CA)
- Senior Regulatory Specialist Located in Westlake Village, CA; Onsite - No remote option. Caldera Medical's Mission - To Improve the Quality of Life for ... Women! In your role as a Sr. Regulatory specialist , you will develop and implement...worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on… more
- J&J Family of Companies (Santa Clara, CA)
- …of America **Job Description:** Position Overview Johnson & Johnson is hiring for a ** Senior Regulatory Affairs Specialist (Remote) - Shockwave** to join our ... with cross-functional team members, compile, prepare, review and submit high-quality regulatory submissions to international regulatory authorities (to… more
- Imperative Care (Campbell, CA)
- …Change Order, CAPAs, NCRs, etc. + Compile, prepare, review and submit high-quality regulatory submissions and filings such as Letter-To-File, 510(k), IDE, PMA, ... Title: Sr Regulatory Affairs Specialist This position is...space preferable. + Proven ability preparing US and/or OUS regulatory submissions and assessing change order assessments.… more
- Edwards Lifesciences (CA)
- …representative in core team meetings in the development of reporting plans and regulatory submissions . + Lead and provide input on other complex cross-functional ... difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international… more
- Charles River Laboratories (Northridge, CA)
- …and standards. This position will also oversee the management of regulatory documentation related to the organization's Institutional Review Board (IRB) activities. ... the Medical Director, Operations Team, etc. to ensure all regulatory documents and requirements are met. This individual will...all IRB activities related to sponsor and study site submissions and approvals for studies where our organization is… more
- Gilead Sciences, Inc. (Foster City, CA)
- …or projects. You will represent Medical Writing on relevant product, project, and/or regulatory submissions teams; providing specialist guidance on the ... is used for a variety of purposes, including critical regulatory submissions . Medical Writing collaborates cross-functionally to...Recognized as a SME in a broad range of regulatory documentation and a resource for specialist … more
- Boehringer Ingelheim (Fremont, CA)
- …contract manufacturing organizations (CMOs) and contract laboratory organizations (CLOs). The Senior Specialist , Supplier Quality Management (SQM) will execute ... **Description** The **Sr Specialist , SQM** role offers a base salary typically...function at Boehringer Ingelheim Fremont (eg, prepares documentation supporting regulatory submissions , actively participates in site readiness… more
- Stanford University (Stanford, CA)
- COI Specialist **Dean of Research, Stanford, California, United States** Administration Post Date Mar 11, 2025 Requisition # 106088 **SCHOOL/UNIT DESCRIPTION:** The ... issues pertaining to and beyond research. **POSITION SUMMARY:** We are seeking a Specialist in Conflict of Interest (COI) Management. The Specialist will report… more
- PNC (San Diego, CA)
- …Advisors organization, you will be based in San Diego, CA. We are seeking a senior level accounting specialist to join our team. The successful candidate will be ... the management of the selling company), evaluating post-closing financial statement submissions (eg, the working capital adjustments) from buyers relating to those… more
- Southern California Edison (Rosemead, CA)
- …legal reports and correspondence and effectively presents legal information to senior management; helps to lead regulatory and enforcement matters ... attentive to detail, identify legal and business risks, and communicate effectively with senior management. We are seeking a candidate who has the ability to… more