- Caldera Medical (Westlake Village, CA)
- …Life for Women! Message from the Hiring Manager: In your role as a Sr. Regulatory specialist , you will develop and implement medical device regulatory ... Sr. Regulatory Affairs Specialist 100% ONSITE in...worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on… more
- Abbott (Alameda, CA)
- …life Sciences, Biology (or equivalent vocational qualifications) + Experienced in regulatory submissions for Pharmaceuticals, medical devices, and/or in vitro ... regulations or with EU and other international medical device regulations and submissions . + Familiar with relevant regulatory requirements for medical devices,… more
- J&J Family of Companies (Santa Clara, CA)
- …Regulatory Agencies and Notified Body + Support publishing of worldwide regulatory submissions in compliance with geography-specific regulatory ... Description:** Johnson & Johnson is hiring for a **Associate Regulatory Operations Specialist - Shockwave Medica** l...requirements + Support verification and quality review of submissions and other responses to regulatory agencies… more
- Abbott (Alameda, CA)
- …presented to substantiate claims. You'll also have opportunities to participate in worldwide regulatory submissions . This is a broad scoped position with strong ... As an individual contributor in the function of a Regulatory Affairs Specialist you will provide support...product release. + Reviews protocols and reports to support regulatory submissions . + Supports all business segment… 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 onsite opportunity working out… more
- Abbott (Alameda, CA)
- ….. The individual has department level influence with experience in global regulatory submissions and on-market changes, and is generally recognized as ... life Sciences, Biology (or equivalent vocational qualifications) . Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or… more
- Astrix Technology (Los Angeles, CA)
- …compensation package. **Responsibilities:** + Prepare & maintain necessary documentation for regulatory submissions , inspections and import activities. + Ensure ... ** Regulatory Affairs Specialist (Global)** Regulatory...to work independently + Demonstrated ability to prepare complex documents/ submissions and presentations INDBH We are an equal opportunity… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Staff Specialist Regulatory Affairs, you will have a deep understanding of Risk Based frameworks, Agile SDLC, experience with ... guidance on device versus non-device functionality. + Prepare, submit, and manage regulatory submissions for SaMD products. + Evaluate the impact of changes to… 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)
- … submissions . Track timelines and documents milestone achievements for inclusion in regulatory submissions . May interact with regulatory agencies as part ... international product submissions + Full knowledge and understanding of global regulatory requirements for new products or product changes + Full knowledge of… more