- Kelly Services (Sunnyvale, CA)
- …licenses, including but not limited to software validation and data entry + The Regulatory Affairs Process Specialist will review change workflows in the ... Kelly(R) Science & Clinical is seeking a Regulatory Affairs Process Specialist for a 6-month contract opportunity with a leading molecular diagnostics company… more
- Abbott (Alameda, CA)
- …questions and negotiate with regulatory agencies during the submission review process to obtain submission approval, working with in-country affiliates ... of quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submission to authorities in Canada and… more
- Abbott (Santa Clara, CA)
- …Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval. **Postmarket:** + Maintain annual ... Monitor impact of changing regulations on submission strategies. + Monitor applications under regulatory review . + Monitor and submit applicable reports to … more
- Abbott (Sylmar, CA)
- …+ Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval + Provide strategic input and ... submission strategies and update internal stakeholders + Monitor applications under regulatory review + Communicate application progress to internal stakeholders… more
- BD (Becton, Dickinson and Company) (Irvine, CA)
- …project(s), propose suggestions on utilizing regulatory updates to expedite approval process + Review labeling content product and process changes, ... inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review ...with regulatory agencies as part of submission review and on-site audit support. (eg, 510(k)'s and CE… more
- Abbott (Alameda, CA)
- …actions. + Negotiate with regulatory authorities during the development and review process to ensure submission approval. + Write and edit technical ... + Represent regulatory affairs in product recall and recall communication process in APAC. + Provide strategic input and technical guidance on regulatory… more
- Edwards Lifesciences (Irvine, CA)
- …project(s), propose suggestions on utilizing regulatory updates to expedite approval process + Review labeling content product and process changes, ... inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review ...with regulatory agencies as part of submission review and on-site audit support. (eg, IDE's, PMA's, annual… more
- Abbott (Santa Clara, CA)
- …+ Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval + Ensure compliance with US and ... of development, quality, preclinical and clinical documentation for submission filing. Compile, prepare, review and submit regulatory submissions to authorities… more
- Abbott (Alameda, CA)
- …enforcement actions. + Negotiate with regulatory authorities during the development and review process to ensure submission approval. + Review and ... monitor and influence changing regulations and guidance, interface with outside regulatory agencies and trade associations, develop innovative regulatory … more
- Abbott (San Diego, CA)
- … authorities. + Negotiate with regulatory authorities during the development and review process to ensure submission approval. + Provide strategic input and ... Ethical guidelines of the regulatory profession, clinical research and regulatory process . **Preferred Qualifications** + A Ph.D. in a technical area or law… more