- Philips (San Diego, CA)
- The Principal Regulatory Affairs Specialist will play a critical role in ensuring Philips Image-Guided Therapy Devices (IGTD) Coronary Vascular (CV) products ... through creative problem solving and high-quality submissions. + Mentor and develop other Regulatory Affairs personnel within IGTD Regulatory . + Present to… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- **Job Description Summary** As Staff Regulatory Affairs Specialist , Infusion, you will be responsible for Regulatory Affairs projects within the ... Medication Management Systems Infusion portfolio. Regulatory Affairs activities, will include: development, execution... agencies. + Working knowledge of medical device stand-alone software , device interoperability and IEC 62304 software … more
- Hologic (San Diego, CA)
- Regulatory Affairs Specialist 3 San Diego, CA, United States Marlborough, MA, United States **Job Summary** Responsible for regulatory compliance ... with a minimum of 5-8 years direct experience in Regulatory Affairs within an IVD or Drug/Biologics...principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices. + Experience with… more
- Philips (San Diego, CA)
- …in obtaining FDA clearances and/or worldwide registrations, clinical trials and software development/ regulatory submissions is a plus and authoring 510K's. ... role you have the opportunity to** Responsible for influencing department regulatory processes and procedures, developing strategies for worldwide regulatory … more