- Medtronic (Irvine, CA)
- …sustaining the current product portfolio. The Sr Specialist has responsibility for compliance with US and EU regulatory requirements and partners with the ... life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with...portfolio. The Sr Specialist has responsibility for compliance with US and EU regulatory requirements… more
- Medtronic (Santa Rosa, CA)
- …solutions. This role will be based in Santa Rosa, CA. The **Principal Regulatory Affairs Specialist ** will support Research and Development programs with early ... life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with...updates in the digital health space. Additionally, the Principal Regulatory Affairs Specialist is expected to play… more
- J&J Family of Companies (Santa Clara, CA)
- …States of America **Job Description:** Johnson & Johnson is hiring for a **Sr Regulatory Affairs Specialist ** **- Shockwave** to join our team located in **Santa ... pressure waves for the treatment of calcified plaque. **Position Overview** The Sr. Regulatory Affairs Specialist is an individual contributor that works closely… more
- Abbott (Santa Clara, CA)
- …submission and approval requirements. + Participate in risk-benefit analysis for regulatory compliance . **Premarket:** + Assess the acceptability of quality, ... Abbott is a global healthcare leader that helps people live more fully...software, vessel closure devices and peripheral stents. This Senior Regulatory Affairs Specialist position is an onsite… more
- Abbott (Alameda, CA)
- …with outside regulatory agencies and trade associations, develop innovative regulatory compliance strategy, and provide executive management with ... Abbott is a global healthcare leader that helps people live more fully...submission. . Write and edit technical documents. . Administer/meet regulatory requirements to achieve excellent compliance status… more
- Abbott (Alameda, CA)
- …regulatory submission. + Write and edit technical documents. + Administer/meet regulatory requirements to achieve excellent compliance status with no ... Abbott is a global healthcare leader that helps people live more fully...our new sensing technology. **The Opportunity** The **Principal RA Specialist - US New Product Introduction** will work on-site… more
- Philips (San Diego, CA)
- … Affairs Business Specialist ** In this role, you will support regulatory compliance and business objectives for our Image-Guided Therapy Devices business ... in reviewing product/solution labeling and related marketing communications to ensure compliance with regulatory guidelines and standards, primarily at the… 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 ... role involves developing and implementing practices for SaMD devices to ensure regulatory compliance , expedition of product clearances and maintain the highest… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …requirements. + Review and approve labels, labeling, and promotional materials to ensure regulatory compliance . Assist in the collection of regulatory ... of possible** with us. **Job Overview** As a Staff Regulatory Affairs Specialist , you will play a...EU Electromagnetic Compatibility Directive, etc.). + Problem-solve and escalate regulatory and compliance issues to senior management… more
- Edwards Lifesciences (Irvine, CA)
- …procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance , consistency, and accuracy + Provide ... content product and process changes, and product documentation to assure regulatory requirements compliance , consistency, and accuracy **What you'll need… more